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In relapsed or refractory multiple myeloma, teclistamab plus daratumumab significantly prolonged progression-free survival as compared with DPd or DVd (83.4% vs. 29.7%) and led to higher response rates.

Gene therapy for cystinosis, a lysosomal storage disease, led to decreased white-cell cystine levels and stopping or decreasing cysteamine; adverse events were mainly consistent with the myeloablative regimen and underlying disease.

Cystinosis is a prototypical lysosomal storage disease caused by recessive pathogenic variants in CTNS, which encodes cystinosin, a ubiquitous proton-driven lysosomal cystine transporter.1 Loss of cystinosin leads to intralysosomal cystine accumulation, impaired lysosomal signaling, defective autophagy, and widespread cellular dysfunction.2-4 The most severe and...

Progress in the treatment of relapsed or refractory multiple myeloma has been rapid since the introduction of T-cell–redirecting immunotherapies. The identification of B-cell maturation antigen (BCMA) led to the approvals of three bispecific antibodies, two chimeric antigen receptor T-cell (CAR-T) therapies, and an antibody drug conjugate. Talquetamab, a bispecific antibody...

A 91-year-old man was admitted to the hospital with weight loss, dyspnea, and eosinophilia. An anteroposterior chest radiograph obtained 2 months earlier showed bibasilar patchy opacities. A diagnosis was made.

In Latin America, though overall smoking rates have declined, nondaily and low-intensity smoking are increasingly common, and tobacco-cessation resources remain underdeveloped in many countries.

Survival in patients with cancer, affected by myriad factors, is notoriously difficult to predict. But while oncologists find it hard to communicate the uncertainty, patients are the ones who must live it.

In cisplatin-ineligible patients with muscle-invasive bladder cancer, enfortumab vedotin–pembrolizumab plus surgery led to better event-free survival (74.7%, vs. 39.4%) and overall survival (79.7%, vs. 63.1%) than surgery alone at 2 years.

Although bladder preservation with trimodal therapy is a category 1 recommendation in the National Comprehensive Cancer Network (NCCN) guidelines for appropriately selected patients with muscle-invasive bladder cancer, the real-world adoption of this type of therapy in the United States remains disappointingly low. Contemporary data suggest that only half the patients...

VITT is caused by a somatic hypermutation of an anti–adenovirus pVII antibody that generates more avid binding of platelet factor 4 than of adenovirus pVII, its original target, which results in platelet activation.

Mucormycosis is a rapidly progressive, invasive fungal infection that causes severe disease. The latest epidemiologic data, risk factors, diagnostic strategies, and treatment approaches are reviewed.

A 60-year-old man presented with a 15-day history of generalized weakness and right upper abdominal pain. Imaging studies revealed diffuse disruption of the hepatic architecture by hyperechoic nodules and areas of necrosis and hemorrhage.

A 49-year-old man with acute myeloid leukemia was evaluated for prolonged neutropenic fever. On examination, there were crackles at the lung bases. CT of the chest revealed a reversed halo sign.

In untreated HER2-positive metastatic breast cancer, trastuzumab deruxtecan plus pertuzumab extended progression-free survival to 40.7 months, vs. 26.9 months with standard first-line therapy, with a similar incidence of high-grade adverse events.

In high-risk biochemically recurrent prostate cancer, enzalutamide plus leuprolide significantly improved overall survival as compared with leuprolide alone. Enzalutamide monotherapy had no significant benefit for survival.

A 29-year-old woman with active opioid, alcohol, benzodiazepine, tobacco, and cocaine use disorders and recent intravenous drug use presented with acute onset of chills and increased pain and drainage of chronic wounds in both legs.

A rare case of spontaneous heparin-induced thrombocytopenia occurred after hip arthroplasty despite no heparin exposure. Severe thromboses developed, but the patient recovered with bivalirudin and IVIG.

Medicare will achieve greater savings on the 15 drugs in its second round of price negotiations than it did in the first round. Despite new challenges, the effort should continue to pay growing dividends.

In acute central retinal artery occlusion treated within 4.5 hours after onset, intravenous tenecteplase did not result in greater recovery of vision at 30 days than aspirin and was associated with serious safety concerns.

In metastatic hormone-receptor–positive, HER2-positive breast cancer, maintenance palbociclib plus anti-HER2 and endocrine therapies extended progression-free survival but increased toxic effects such as neutropenia.

Along with ongoing wars, territorial disputes, and instability in regions such as the Middle East, Europe, Latin America, and parts of Africa, there are continued changes and power shifts in the complex and turbulent geopolitical landscape. Unpredictable decisions with international consequences by the USA, under the leadership of President Donald J Trump, are of particular concern and are causing widespread political mayhem and impacting global stability, international cooperation, economic development, security, and humanitarian issues.

The therapeutic landscape of early-stage EGFR-mutated non-small-cell lung cancer (NSCLC) has been irreversibly transformed by adjuvant EGFR tyrosine-kinase inhibitors.1 This paradigm shift began with the ADAURA trial, which established postoperative osimertinib as the first adjuvant targeted therapy to deliver durable survival benefit in molecularly defined NSCLC.2,3 Its effects extended beyond recurrence delay, providing clear evidence that early systemic intervention can improve cure rates and prevent metastatic relapse, especially in the brain.

Metastasis-directed therapy (MDT) delivered via stereotactic body radiotherapy has gained substantial attention over the past decade. Landmark trials such as STOMP1 and ORIOLE2 fundamentally shifted the management paradigm for metastatic prostate cancer. These pioneering studies showed improved progression-free survival in patients with up to three metastases compared with observation alone (HR 0·60, 95% CI 0·40–0·90 in STOMP; HR 0·30, 0·11–0·81 in ORIOLE). Subsequent phase 2 trials further expanded these findings: the EXTEND trials3,4 reported a progression-free survival benefit in patients with recurrent or de novo metastatic disease (five or fewer lesions) when MDT was added to either intermittent or continuous androgen deprivation therapy (ADT; HR 0·45, 0·30–0·69 in the combined analysis), and the RADIOSA5 study observed improved clinical progression-free survival with stereotactic body radiotherapy plus 6 months of ADT compared with stereotactic body radiotherapy alone (HR 0·43; 0·26–0·72).

Clear cell gynaecological tumours represent a paradigmatic example of the challenges of rare cancers, in which scarce clinical evidence contrasts with high unmet need, often affecting younger patients and raising concerns about equitable access to innovation. In The Lancet Oncology, Natalie Y L Ngoi and colleagues report the LARA (GCGS-OV4/APGOT-OV3) single-arm, multicentre, phase 2 trial of pembrolizumab plus lenvatinib in recurrent clear cell gynaecological cancer.1 Beyond its clinical findings, the study highlights the limitations of current evidentiary and regulatory frameworks for rare tumours.

In cancer trials, clinical investigators report and grade adverse events on behalf of their patients via the Common Terminology Criteria for Adverse Events (CTCAE) scale—including for highly subjective events such as fatigue, nausea, or sensory neuropathy. However, this approach has been found to be unreliable.

The recent media coverage of interim results from the PATHFINDER2 study of GRAIL's Galleri multicancer detection blood test exemplifies a troubling and recurring trend in science communication: the commercially driven, premature framing of non-peer-reviewed data as proof of a transformative breakthrough. Released via an embargoed press statement on Oct 17, 2025, and then presented as a late-breaking abstract at the European Society for Medical Oncology (ESMO) Congress,1 the study's hand-picked performance metrics prompted a wave of enthusiastic, uncritical reporting across mainstream media outlets.

Oral cancer, ranked among the 16th most common cancers globally, represents a major public health burden.1 In some countries in south Asia, oral cancer is the most frequent cancer among men. A recent systematic analysis for the Global Burden of Disease study concluded that insufficient action in the past three decades has led to little change in population oral health, underscoring the necessity for renewed strategic focus.2

Over recent decades, advances in cancer treatment have yielded substantial improvements in patient outcomes, driving up survival, and even rendering some cancers curable. These advances have been achieved not only by remarkable scientific breakthroughs, but also by unprecedented financial investment in research and development, including the conduct of clinical trials of a size and complexity only feasible by the involvement of the commercial sector, predominantly, the pharmaceutical industry. However, therein lies a tension: the need to explore scientific truths versus a financial return on investment.

Alfredo Addeo

Salomon Manier and colleagues show that, in patients aged 65 years or older with newly diagnosed multiple myeloma selected for frailty, a regimen of lenalidomide plus daratumumab with dexamethasone confined to the first two cycles achieves markedly longer progression-free survival than continuous lenalidomide–dexamethasone, with an accompanying overall survival benefit and no clear excess of serious infections.1 For a population in whom steroids are often viewed as unavoidable, showing that a predominantly steroid-free backbone can be delivered for a median of almost 3 years is an important achievement.

We thank Yunfeng Fu and colleagues for their important comments on the IFM2017-03 trial1. We provide below the most accurate information available to address their remarks.

Samual X Stevens and colleagues advocate overall survival as the decisive trial endpoint.1 The authors overstate their case in saying that, “Oncology literature abounds with examples where reliance on putative surrogate endpoints has resulted in increased deaths.” They note that immunotherapy decreased myeloma overall survival, but the implication that surrogate endpoints suggested immunotherapy benefit was incorrect. Neither response rates nor progression-free survival indicated significant benefit.

We were surprised to read the letter from David J Stewart and colleagues in response to our Comment because they dismiss overall survival—the endpoint that patients have consistently reported as most meaningful1—as difficult and unreliable. We agree that measuring overall survival is difficult, but that cannot be an excuse to not measure it. We disagree that overall survival is unreliable. The literature is abound with plenty of examples where reliance on surrogates has caused harms and assert that ARIEL4 is one more example in that long list.

In 1971, Julian Tudor Hart wrote that “the availability of good medical care tends to vary inversely with the need of the population served”.1 Amid extraordinary progress in precision therapy, a quieter crisis has emerged viz the loss of the human face of cancer care. The Lancet Oncology Commission from Gary Rodin and colleagues on the human crisis in cancer2 exposes this paradox: that even as survival improves, the experience of illness often grows more fragmented, impersonal, and inequitable. Patients and their families shoulder catastrophic expenses without psychosocial support.

Stefano Kim and colleagues1 report promising activity from a combined neoadjuvant strategy using ezabenlimab (an anti-PD-1) with modified docetaxel, cisplatin, and fluorouracil (mDCF) followed by personalised intensity-modulated radiotherapy with involved-node chemoradiotherapy (INRT) in patients with stage 3 squamous cell anal carcinoma (SCAC). In this phase 2 trial, Kim and colleagues showed high rates of pathological (41 [84%] of 49 evaluable patients) and biological complete responses (36 [90%] of 40), concordant improvements in clinical complete response at 40 weeks (overall 77·8% [90% CI 66·5–86·7]), and encouraging early survival estimates (in a post-hoc analysis).

We thank Bhumesh Tyagi and colleagues for their comments. INTERACT-ION was designed to show the feasibility and preliminary efficacy of induction with modified docetaxel, cisplatin, and fluorouracil (mDCF) plus ezabenlimab then intensity-modulated radiotherapy with involved-node chemoradiotherapy (INRT) in patients with locally advanced squamous cell anal carcinoma (SCAC).1 We showed the value of this novel induction regimen, with 38 (75%) of 51 patients reaching a major response and becoming eligible for INRT with only four (11%) recurrences, suggesting that induction chemoimmunotherapy followed by INRT is a promising strategy for patients with locally advanced SCAC.

Cattley RC, De Roos AJ, Mandrioli D, et al. Carcinogenicity of atrazine, alachlor, and vinclozolin. Lancet Oncol 2026; 27: 11–12—In this News, the meta-odds ratio in the second sentence of the fifth paragraph should have been 1·99; 95% CI 1·13–3·53. This correction has been made to the online version as of Feb 2, 2026.

Sun J-M, Chao Y, Kim S-B, et al. First-line tiragolumab plus atezolizumab and chemotherapy in patients with previously untreated, locally advanced unresectable or metastatic oesophageal cancer (MORPHEUS-EC): a randomised, open-label, phase 1b/2 trial. Lancet Oncol 2026; 27: 90–102—This Article was published with the incorrect appendix file. The file has been corrected as of Feb 2, 2026.

In the phase 3 IidERA trial presented by Aditya Bardia (University of California Los Angeles, Los Angeles, CA, USA), adjuvant giredestrant, an oral selective oestrogen receptor degrader (SERD) showed significant improvement in invasive disease-free survival (iDFS) compared with standard-of-care endocrine therapy in patients with early-stage HR+ HER2– breast cancer. 4170 patients were randomly assigned (1:1) to receive either 30 mg of giredestrant or tamoxifen, letrozole, anastrozole, or exemestane.

Sperm from an otherwise healthy sperm donor—some of which harboured the TP53 gene mutation that causes a 90% lifetime cancer risk due to development of Li Fraumeni syndrome if passed to conceived children—has been used to father at least 197 children across Europe. Some of these children have already died from various cancers, and others have developed one or more cancers.

Global tobacco control measures have led to substantial decrease in the number of tobacco users—from 1·38 billion in 2000 to 1·20 billion in 2024, but there are concerns over possible undermining of these measures in some countries, due to untoward activities including illicit tobacco trade and interference of the tobacco industry in policy making.

Almost 70 million acres of US farmland might be contaminated with cancer-causing perfluoroalkyl and polyfluoroalkyl substances (PFASs), according to estimates from biosolids industry groups.

WHO is calling on governments to raise taxes on alcoholic beverages and sugary drinks after two new reports show both have become cheaper over the past few years. National tax policies should ensure these unhealthy products become less affordable over time, highlights WHO. However, the reports released on Jan 13, 2026, reveal that only 37 countries have achieved this trend for beer and only 34 for sugar-sweetened carbonated drinks. Allowing sugary drinks and alcohol to become more affordable will result in a rise in non-communicable diseases and injuries, warns WHO.

Under the Trump Administration, the US Environmental Protection Agency (EPA) plans to stop considering the lives and money saved by controlling air pollution caused by two pollutants—fine particulate matter (PM2·5) and ozone—while setting clean-air rules. According to the plan, instead of calculating the monetary value of saving human lives, EPA will focus only on the cost to the industry while setting rules for the pollution limits of PM2·5 and ozone.

Dirk De Ruysscher, *Pim J J Damen

Aumolertinib showed substantial clinical benefits as adjuvant therapy in Chinese patients with stage II–IIIB EGFR-mutated NSCLC. The manageable safety profile of aumolertinib supports its suitability in the adjuvant setting.

FET-PET-based target volume delineation for re-irradiation did not lead to a significant clinical benefit compared with CE-T1MRI-based treatment in patients with recurrent glioblastoma. Thus, CE-T1MRI remains the preferred delineation method in this setting.

WOLVERINE showed a benefit with MDT for oligometastatic prostate cancer in progression-free survival, radiological progression-free survival, and castration resistance-free survival. Overall survival benefit was not significant and further research is needed.

Progression-free status at 24 months was a strong prognostic marker for overall survival at the patient level in HPV-positive oropharyngeal cancer and future trial-level analysis is now warranted. The adoption of this endpoint has the potential to accelerate therapeutic development by enabling earlier evaluation of treatment activity, thereby facilitating the timely introduction of novel therapies to this patient population before the availability of mature overall survival data.

Pembrolizumab plus lenvatinib showed promising anti-tumour activity and manageable safety in patients with recurrent CCGC, including in patients with disease progression following previous treatment with anti-angiogenic therapy. These findings support further evaluation of this combination in randomised controlled trials.

Correcting inequalities in implementation of minimally invasive surgical resection has the potential to reduce inequalities in colon cancer outcomes.

Cabozantinib with temozolomide showed a meaningful clinical benefit and could potentially be a viable treatment option for patients with unresectable or metastatic leiomyosarcoma. Treatment was tolerable and did not reveal any new safety signals.

Availability of PRO data to providers for CTCAE rating improves the consistency of provider-based symptomatic adverse event detection in patients with cancer. PRO data supports reliable assessment of treatment-related toxicity, highlighting the value of integrating PRO data into clinical evaluations within cancer trials.

Our model provides the basis for a clinically applicable deep-learning assistant to improve human efficiency and accuracy of CNS tumour diagnosis. The model will be made publicly available and could be implemented to assist human pathologists in future prospective studies.

The significantly improved overall survival and patient-reported measures in CARTITUDE-4 reinforce the use of cilta-cel in treating relapsed or refractory multiple myeloma as early as after first relapse.

This Review underscores qualitative research as an indispensable facet of scientific inquiry to improve provision of safe, effective, and affordable care for patients with cancer worldwide. Representing a global working group of applied qualitative researchers, our multidisciplinary authorship team defines qualitative research, characterises its purpose and value, and describes specific ways in which qualitative inquiry is central to advancing cures, treatment, and quality of life in oncology. In this Review, we put forward an imperative for the use of qualitative methods to assess context, understand population needs, design interventions, optimise implementation, and investigate mechanisms of action underpinning changes in health outcomes.

Qualitative research is essential in addressing unresolved problems in oncology, yet high-yield strategies to bolster qualitative approaches in cancer research are scarce. To promote the unique strengths of qualitative research and increase uptake in the field of oncology, qualitative methods should show quality and credibility on par with quantitative methods. This Review presents recommendations for applied qualitative cancer research generated by multidisciplinary experts who were invited to attend the Symposium on Applied Qualitative Research, held on Nov 11–12, 2024, based on their contributions to the field.

As cancer survivors live longer, technologies improve, and reirradiation (reRT) becomes more common, standardised methods for the assessment and reporting of cumulative radiation doses are needed to allow treatment optimisation and integration with other medical specialties managing these complex patients. This consensus statement, developed by an international collaboration of radiation oncologists, physicists, and other experts in the Reirradiation Collaborative Group, proposes a framework for consistent evaluation, documentation, reporting, and clinical decision making in reRT.

Malignant spinal cord compression (MSCC) is a serious complication of spinal metastases and primary spinal tumours that can severely affect quality of life and overall survival. Clinical trials have used inconsistent definitions, criteria, and endpoints, limiting comparability. We conducted a Delphi consensus process following a systematic review of prospective MSCC trials from Jan 1, 2003, to Feb 26, 2024. From June 25, 2024, to Jan 11, 2025, experts from 20 countries participated in two survey rounds, 74 in round 1 and 71 in round 2.

Vibostolimab coformulated with pembrolizumab did not provide additional clinical benefit versus pembrolizumab as adjuvant therapy in participants with resected stage IIB–IV melanoma. Pembrolizumab monotherapy remains a standard of care for resected high-risk melanoma.

On Feb 4, 2026, Health Minister Stéphanie Rist announced that the French Government will launch a targeted lung cancer screening trial in March, 2026, with the aim of making screening systematic by 2030.

The UK National Health Service (NHS) will meet all three core cancer standards by 2029, according to a new National Cancer Plan for England, published on Feb 4, 2026. This is despite national treatment targets having not been hit for more than a decade.

On Jan 27, 2026, India and the EU announced the conclusion of a comprehensive free trade agreement (FTA) as part of the 16th EU–India Summit, held in New Delhi, India. The new agreement creates a free trade zone affecting more than 2 billion people by eliminating or reducing tariffs on chemical inputs, medical devices, and pharmaceuticals, including cancer drugs.

This 10-year follow-up confirms the non-inferiority of the ultra-hypofractionated radiotherapy regimen compared with the conventionally fractionated, with similar toxicity profiles. The findings support the seven-fraction schedule as a safe, effective, and practical standard-of-care option for patients with intermediate-risk prostate cancer.

Lithuania has now joined a growing list of more than 100 countries worldwide that have introduced a tax on sugar-sweetened beverages (SSBs). The tax, introduced from Jan 1, 2026, means the Baltic nation is one of many countries using fiscal policies to help encourage healthier diets across its population. Lithuania will also be taxing artificially sweetened beverages.

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) began as therapies for type 2 diabetes but have become a breakthrough therapy for obesity, redefining its treatment and broader metabolic landscape. They have lit up medicine, popular culture, and global markets as new benefits and controversies unfold, with no field of medicine immune. By mimicking GLP-1 physiology, these drugs have come a long way, from the US Food and Drug Administration approval to treat type 2 diabetes in 2005 to approval to treat obesity in 2014, peaking with the 2021 subcutaneous weekly semaglutide regimen that delivered unprecedented weight loss.

Chimeric antigen receptor T-cell therapy (CAR-T) and bispecific antibodies (BsAb) are T-cell redirecting therapies that have revolutionised the treatment landscape for relapsed or refractory large B-cell lymphoma. However, the optimal sequencing of these treatments remains elusive.1

Heitmann JS, Maringer Y, Jung S, et al. Personalised multipeptide-based T-cell activator for chronic lymphocytic leukaemia: an open-label, single-centre, phase 1 study. Lancet Haematology 2026; 13: e74–85—In this Article, Ariane Metzger's surname and Melissa Zwick's degree qualification were amended. Mark Polster's affiliations should have been “Quantitative Biology Center (QBiC), University of Tübingen, Tübingen, Germany”, “Department of Peptide-based Immunotherapy, University and University Hospital of Tübingen, Tübingen, Germany”, and “Department of Computer Science, University of Tübingen, Tübingen, Germany”.

Hisham Abdel-Azim (Loma Linda, CA, USA) and colleagues presented results from the multicentre phase 2 EndRAD trial (NCT03509961) examining myeloablative non-total-body-irradiation conditioning regimens for allogeneic HSCT in patients (aged 1 year to <31 years) with B-ALL at lower relapse risk. 51 patients underwent HSCT and, at a median follow-up of 2·3 years (range 0·2–6·0), the primary endpoint of 2-year event-free survival (EFS) was 76·3% (95% CI 61·1–86·1). Transplant-related mortality in the first 100 days after HSCT was 2%.

In his father's small grocery store in Mexico City, Jorge Cortes learnt the meaning of hard work. Learning English from an early age and with parents who placed high importance on studying, Cortes, now director of the Georgia Cancer Center in Augusta, GA, USA, was talked out of becoming a dentist by his grandfather. “He was very influential in my life, and he said to me ‘You're too smart. Why don't you go for the whole thing, not just the mouth,’” Cortes recalls.

Chlorosis (c.1899) by Sebastià Junyent captures the viewer's attention with its muted tone (figure). We see a young woman slumped in her chair, her pale skin set against an interior of olives and greys. Supporting the woman is a second character wearing a blue dress with rosy red cheeks, providing a picture of healthy complexion in comparison. The contrast is deliberate: pale beside rosy, slumped besides upright. This chromatic choice would be recognised by 19th century viewers as chlorosis—also known as the green sickness—which comprised fatigue, pallor, and amenorrhoea in adolescent girls and young women.

Four interventions used to prevent donation-related vasovagal reactions showed no clear benefits compared with standard practices in England, suggesting potential policy implications for blood services worldwide to streamline donation practices and save resources.

Our findings indicate that iTAC-XS15-CLL01 could be a potent immunotherapeutic agent in patients with chronic lymphocytic leukaemia and should be further evaluated in phase 2 trials.

Based on current evidence, our meta-analysis suggests that BsAb therapy before CAR-T could improve future CAR-T effectiveness for large B-cell lymphoma, although our conclusions are limited by small sample sizes. Nonetheless, our findings have important implications for the design of randomised controlled trials to identify the optimal treatment sequence of CAR-T and BsAb.

These findings support the beneficial effect of resminostat maintenance therapy in patients with advanced CTCL. The overall safety profile of resminostat was acceptable, with gastrointestinal side-effects occurring most frequently. Anti-emetic prophylaxis should be considered in the future to manage side-effects and to improve tolerability and adherence to maintenance therapy.

Haematological disorders constitute a public health crisis in more than 160 countries worldwide. Despite millions afflicted, people with haematological diagnoses remain underserved and understudied. This Review, one of four companion Reviews on qualitative research published in The Lancet Oncology, The Lancet Haematology, and eClinicalMedicine, reports findings from a symposium of international multidisciplinary experts in applied qualitative research, highlighting the purpose and added value of qualitative research for improving health outcomes for people with haematological disorders and their communities.

There is a major unmet need for substantially more effective therapy for myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML), but improving on use of hypomethylating agents, which have marginal benefit for many patients, has proved difficult. Stahl and Zeidan summarize lessons learned from multiple negative phase 3 trials of once-promising new agents of different classes and cogently propose how we can be more successful in future studies. They advocate for an emphasis on biological classification, specific handling of cases with TP53 inactivation, and application of modern response criteria. Of course, we also need new agents with potential beyond that of recent failures in order to maximize the benefits of heeding the authors’ advice.

The French Group for Research in Adult Acute Lymphoblastic Leukemia (GRAALL) was among the first to demonstrate how use of pediatrics-inspired protocols improved outcomes for adults with ALL. While conceived before widespread use of immunotherapy, the subsequent GRAALL-2014 trial, which included 743 adult patients with B-cell or T-cell ALL, reflects modern outcomes and the impact of measurable residual disease (MRD) assessments. Boissel and colleagues report that, in comparison to matched historical controls, long-term disease-free survival is improved, reflecting higher complete remission rates, reduced treatment-related mortality, and more judicious MRD-directed use of allogeneic transplantation.

T-cell-redirecting therapies are rapidly transforming the treatment landscape of multiple myeloma (MM), but there are major limitations evident in durability and universality of responses seen with targeting single antigens. Pillarisetti et al describe ramantamig, a first-in-class trispecific T-cell engager (TCE) that redirects CD3⁺ T cells against both B-cell maturation antigen (BCMA) and G-protein–coupled receptor class C group 5 member D (GPRC5D), both of which are clinically validated antigen targets on myeloma cells. The extensive in vitro and in vivo preclinical studies with cell lines and patient samples indicate strong potential for this agent to have efficacy against MM expressing either or both of these antigens.

Epstein-Barr virus (EBV) relies on its EBV nuclear antigen 1 (EBNA1) protein for viral persistence and oncogenesis. Stewart and Damania demonstrate that withaferin A enhances degradation of EBNA1, as well as increasing oxidative stress, and inhibits EBV⁺ tumor cells both in vitro and in a humanized mouse model of EBV-driven lymphomagenesis. This work should revitalize attempts at targeting critical virus-specific proteins with small molecules to treat EBV-driven diseases.

Their heightened dependence on mitochondrial energy production makes acute myeloid leukemia (AML) cells particularly vulnerable to loss of mitochondrial function. Opening of the mitochondrial permeability transition pore (mPTP) leads to loss of mitochondrial membrane potential and apoptosis. Ling and colleagues reveal that the glutathione-dependent oxidoreductase glutaredoxin 2 (GLRX2) is upregulated in AML cells and that, through its deglutathionylating action on a component of electron transport chain complex V, this increases closure of the mPTP, linked to AML resistance to chemotherapy. Loss of GLRX2 function results in sustained opening of the mPTP, identifying it as a potential future target for AML therapy.

While pharmacological prophylaxis for venous thromboembolism (VTE) in adults in critical care units halves the risk of venous thrombosis from 15% to 7%, the background average risk of VTE in children in critical care is only 2%, precluding recommendation of universal prophylaxis. In this month’s CME article, Jaffray and colleagues in the Children’s Healthcare Advancements in Thrombosis (CHAT) Consortium validate a risk assessment model for venous thrombosis in critically ill children through a study of 4674 patients across 32 institutions. Their work identifies patients with risks as high as 17% and takes us one step closer to the goal of personalized thromboprophylaxis for safe and effective care of high-risk children.

The gut microbiome plays a critical role in maintaining gastrointestinal homeostasis and contributes to the pathogenesis of graft-versus-host disease (GVHD). Gurer Kluge et al identify calprotectin, a neutrophil granule–derived protein with antimicrobial properties whose concentration in the stool is a diagnostic tool for inflammatory bowel disease, as a mucosal marker correlating with acute gastrointestinal GVHD (aGI-GVHD) severity and transplant-related mortality. Further, they correlate use of broad-spectrum antibiotics with calprotectin suppression and propose that neutrophil tissue infiltration during acute GVHD is linked to bacterial translocation.

Second‐line CAR‐T therapy significantly improves long‐term survival and disease control in R/R LBCL, with consistent benefit across subgroups and real‐world settings. These findings support early CAR‐T use as a standard strategy in high‐risk LBCL, while emphasizing the importance of timely delivery and long‐term monitoring.

The results highlight the need for disaggregation of oral cavity cancer sites in etiologic studies and reappraisal of widely accepted smoking/alcohol relative risks/attributable fractions.

Cabozantinib and pembrolizumab combination was explored in treatment‐naive aCM. Toxicity was consistent with known profiles, but discontinuation rates were notable.

Bortezomib‐based regimens were effective and achieved favorable long‐term survival outcomes for patients with newly diagnosed POEMS syndrome.

Single‐dye SLNB after NAT in patients initially diagnosed with cN1 breast cancer yielded a clinically acceptable FNR. When four or more SLNs were identified, an additional benefit was observed in patients who had a BMI <25 kg/m2 and negative estrogen receptor status.

Prognostic stage significantly influences survival among patients with low RS. RS < 11 alone should not automatically downstage patients to PPS IA; anatomic and other nongenomic factors remain important for prognosis.

These findings highlight the prognostic significance of cytopenia dynamics during ruxolitinib therapy and support the use of cytopenia trajectory monitoring as a valuable tool for risk stratification and treatment optimization in myelofibrosis.

These findings demonstrate the feasibility and impact of a robust approach to reach, engagement, and abstinence among racially and socioeconomically diverse patients with cancer, and the potential for improving disease‐related survival among the most vulnerable patients.

Many questions remain about management of PC related to biomarker‐based risk stratification to guide treatment selection, use of prostate‐specific membrane antigen‐positron emission tomography, and balancing the risk for PC‐related death with risks for treatment‐related toxicity. Ongoing research efforts are needed to optimize risk‐based treatment, sequence of therapies throughout the disease continuum, and survivorship care.

In the current era, lower baseline AFP levels are associated with improved diagnostic performance of AFP for HCC. Adoption of a 5 ng/mL AFP cutoff and 40 mAU/mL DCP cutoff appears appropriate for current clinical practice.

Associations between historical redlining and breast cancer survival have changed over time, with disparities generally narrowing. Results stratified by stage and hormone receptor status suggest that such disparities reflect differential access to advances in breast cancer treatment across time.

Control arm overperformance is common in phase 3 oncology RCTs and is associated with trial outcomes, suggesting an effect on study power. Because overperformance appears to be especially prevalent when OS is the primary end point, the effects of postprogression therapies on OS may be underappreciated. Alternative strategies for designing trials should be considered for reliable estimation of treatment effects.

ICG is a safe and effective adjunct for SLNB in pediatric and AYA soft tissue and skin malignancies.

: Stereotactic ablative radiotherapy (SAbR) is increasingly employed to treat limited sites of oligoprogression in metastatic renal cell carcinoma (OP-mRCC) during systemic therapy (ST). The patient subgroups most likely to benefit remain undefined.

Purpose: We developed a risk-adjusted surveillance strategy incorporating prognostic factors for disease-free survival (DFS) in patients with extrahepatic bile duct (EHBD) cancer after curative resection and lymph node dissection.Methods and Materials: After ethical approval with informed consent waived, this retrospective analysis included 1,443 patients with EHBD cancer treated between 2000 and 2015 (median follow-up, 35.9 months). DFS, defined as the time from surgery to recurrence or death, was analyzed using multivariate Cox proportional hazards models to identify prognostic factors.

Curative-intent pelvic radiation for cervical cancer causes premature ovarian insufficiency (POI) in premenopausal patients. Despite evidence-based recommendations for hormone replacement therapy (HRT) to treat POI, prior studies have shown low HRT use among cervical cancer survivors, particularly those treated with radiation. This study evaluates the impact of practice quality improvement (PQI) initiative within a radiation oncology department on the rates of HRT prescriptions, POI documentation, and counseling.

This study evaluated whether the difference in total Medicare costs between active surveillance (AS) vs. radiotherapy (RT) changed over time for men with low- or favorable-intermediate risk prostate cancer.

Purpose: This cross-sectional study examines disparities in access to radiotherapy (RT) across Brazil, a country with a population exceeding 210 million, focusing on the distances traveled by cancer patients to receive RT. Using data from 2017 to 2022, the study aimed to assess geographical barriers to radiation therapy access and regional inequities.Methods and Materials: Data from the Brazilian National Outpatient Procedure Authorization (APAC) system were collected as .dbc files and processed using Python.

The majority of Head and Neck Squamous Cell Carcinoma (HNSCC) patients receives radiotherapy (RT) as part of their treatment plan. Even though RT is highly effective in HNSCC, therapeutic efficacy for advanced HNSCC is relatively low; a third of radiotherapy-treated HNSCC patients experiences locoregional relapse within 5 years after treatment. Cancer-associated fibroblasts (CAFs) are one of the most prominent cell types in the tumor micro-environment (TME) in advanced HNSCC and play a key role in therapy resistance.

EBRT-derived tolerance doses for long-term radiation toxicity (e.g., 23 Gy kidney limit) are routinely applied to radioligand therapy (RLT) for dosage selection in clinical trials. However, these thresholds are independent of the RLT molecule or patient populations, potentially leading to inaccurate toxicity assessments and suboptimal treatment.

Thyroid dysfunction is a common complication of breast regional nodal irradiation (RNI). Proton therapy has been posed as a means to spare normal tissue. We prospectively evaluated the incidence of hypothyroidism in a cohort of patients receiving RNI on a randomized trial comparing proton to photon modalities. A secondary objective was to evaluate the associations between thyroid dose-volume metrics and the risk of subsequent hypothyroidism.

Although MRI is the gold standard for image guided brachytherapy (IGBT) for cervix cancer, CT scan is widely used. However, there is dearth of comparative evidence.

Purpose Stereotactic radiosurgery (SRS) is an effective treatment for brain arteriovenous malformations (AVMs), though radiation-induced adverse events (RAEs)—including peri-nidal T2 signal changes and late radiation-induced complications (LRICs)—remain concerns. We evaluated whether brain V12 (volume of surrounding brain receiving ≥12 Gy) predicts RAEs, including chronic encapsulated hematoma and cyst formation.Methods and Materials We retrospectively reviewed 317 patients who underwent SRS at a single institution between 1998 and 2020.

High dose rate Brachytherapy (HDR BT) is an effective but resource-intensive treatment modality, demanding a highly skilled workforce, team coordination, and logistics. This study presents findings from a comprehensive national survey conducted in 2023, targeting all XXX sites in the United States.

Radiation-induced brain injury (RIBI) is partially defined by vascular injury, which contributes to long-term cognitive decline. RIBI is irreversible and progressive, highlighting the importance of early identification. Magnetic resonance imaging provides an opportunity to non-invasively detect vascular injury

Clinical trials suggest that adjuvant radiotherapy (RT) may be omitted in women aged 65 or older with early-stage, hormone-receptor (HR) positive breast cancer provided completion of 5 years of endocrine therapy (ET). However, at the time of RT consult, it is often unknown whether the patient will start ET or will start but not complete 5 years, either of which, if known in advance, would alter RT recommendations. We studied a cohort of patients who would have been eligible for RT omission to examine factors associated with declining or discontinuing ET.

In this prospective observational study, we evaluated dose-response relationships between radiation dose to the brain’s resting-state networks (RSNs) and neurocognitive function (NCF) changes following radiation therapy (RT) in adult patients with diffuse glioma.

To develop a competency-based simulation program to evaluate medical physics residents in radiation output measurements and clinical decision making.

The use of cardiac stereotactic body radiation therapy (SBRT) for the treatment of ventricular tachycardia (VT), also termed stereotactic ablative radiotherapy (SABR) or, increasingly, stereotactic arrhythmia radioablation (STAR), is increasingly utilized in select patients. STAR has emerged as a promising alternative to invasive catheter ablation (CA) for patients with high-risk refractory VT who have failed prior medical therapy or CA. Since the publication of the first case series using STAR, our understanding of the mechanisms of STAR, longer-term clinical outcomes, potential side effects, and barriers to widespread adoption of cardiac radioablation has become increasingly clear.

The use of oxybutynin led to statistically significant reductions in the number of hot flashes per day compared with placebo for men with prostate cancer receiving androgen-deprivation therapy (ADT), according to findings from the Alliance A222001 trial published in the Journal of Clinical...

In a meta-analysis reported in JAMA Oncology, Zaorsky et al found that longer durations of androgen-deprivation therapy given with definitive radiotherapy were associated with nonlinear relative benefits in patients with localized prostate cancer.  

In a French phase II trial (IMMUNEBOOST-HPV) reported in the Journal of Clinical Oncology, Mirghani et al found that use of induction nivolumab prior to chemoradiation (CRT) did not meet the endpoint of ‘receipt of full treatment in due time’ (FTDT) in patients with high-risk human papillomavirus...

In a Chinese phase III trial (neoCARHP) reported in the Journal of Clinical Oncology, Gao et al found that neoadjuvant therapy with a taxane plus trastuzumab and pertuzumab (THP) was noninferior in pathologic complete response (pCR) compared with THP plus carboplatin (TCbHP) in patients with stage...

Aromatase inhibitors are a cornerstone of adjuvant therapy for hormone receptor–positive breast cancer, significantly reducing recurrence and mortality. However, by suppressing estrogen production, aromatase inhibitors can accelerate bone loss and increase fracture risk. To counter this,...

The American Society of Hematology (ASH) released guidelines on front-line management of acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs), as well as the management of relapsed or refractory disease in this population. Both guidelines, grounded in evidence-based practice,...

Treatment with a single injection of an oncolytic virus induces persistent T cell–mediated immunity in glioblastoma, according to findings from a trial published in Cell. 

In a phase III trial (Canadian Cancer Trials Group BR.31) reported in the Journal of Clinical Oncology, Goss et al found that adjuvant durvalumab did not improve disease-free survival vs placebo in patients with completely resected early-stage non–small cell lung cancer (NSCLC).

The U.S. Food and Drug Administration (FDA) has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for these drugs. Specifically, risk statements related to cardiovascular disease, breast cancer, ...

In a nationwide Korean cohort study reported in the Journal of Clinical Oncology, Park et al found that risk of young-onset pancreatic cancer was associated with increased consumption of alcohol and increased frequency of alcohol consumption.

The American Society of Clinical Oncology (ASCO®) and Conexiant today announced the launch of ASCO AI in Oncology, a premier digital destination designed to help oncology professionals navigate the transformative role of artificial intelligence (AI) in cancer care. Launching this initiative marks...

As reported in JAMA Network Open by Awan et al, both histopathologic and demographic factors show distinct time-dependent associations with colorectal adenoma recurrence in postpolypectomy surveillance.

The American Society of Hematology (ASH) has released clinical practice guidelines on the diagnosis of light chain (AL) amyloidosis, which were published in Blood Advances. Additionally, the expert panel behind the guidelines also published a scoping review about the clinical features of systemic...

The U.S. Food and Drug Administration (FDA) has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. Optune Pax, developed by Novocure, is a portable, noninvasive device that delivers alternating electrical fields, known as tumor treating...

In a Swedish trial (MASAI) reported in The Lancet, Gommers et al found that artificial intelligence (AI)-supported mammography was noninferior to standard double reading without AI in identifying interval breast cancers in women undergoing breast cancer screening.

A national survey of independent community oncology practices has found that utilization management tactics imposed by health insurers and pharmacy benefit managers (PBMs) delay cancer treatment, interfere with physician-directed care, and increase administrative and financial burdens on practices...

New research published by Nikitas et al in JNCCN—Journal of the National Comprehensive Cancer Network found that incorporating information from prostate-specific membrane antigen (PSMA) positron-emission tomography/computed tomography (PET/CT) scans may be able to predict progression-free survival...

Earlier this week, 25 health-care organizations proposed that the Health and Human Services Office of Inspector General adopt a new regulatory safe harbor from the Anti-Kickback Statute that would allow clinical trial sponsors to financially support patients to offset indirect or nonmedical costs...

On February 10, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian,...

A nationwide, real-world analysis using the Society of Thoracic Surgeons (STS) General Thoracic Surgery Database (GTSD) from 2012 to 2023 evaluated over 16,000 adults who underwent esophagectomy for primary esophageal cancer to develop and validate a long-term all-cause mortality risk model. The...

As reported in the Journal of Clinical Oncology by Tung et al, findings in expansion cohorts of the phase II Translational Breast Cancer Research Consortium (TBCRC) 048 study showed that olaparib was active in patients with metastatic breast cancer with germline PALB2 mutations (gPALB2m) and in...

In an Indian single-center phase III trial (DELII) reported in the Journal of Clinical Oncology, Noronha et al found that “ultra–low-dose” immune checkpoint inhibitor therapy with the PD-1 inhibitor nivolumab was associated with improved overall survival vs standard chemotherapy among patients with ...

In a phase III single-blind randomized clinical trial reported in JAMA Network Open, Zick et al found that self-acupressure—taught via a mobile app—provided a safe, low-cost approach for managing fatigue in ovarian cancer survivors.

Testing menstrual blood for human papillomavirus (HPV) could be a “robust alternative or replacement” for current cervical cancer screening by a clinician, according to findings from a Chinese study published by Tian et al in The BMJ.

The first unified, pan-tumor guideline framework has been released for how pathologists should evaluate and score response in the neoadjuvant setting. These consensus guidelines, which were a joint effort by the Society for Immunotherapy of Cancer's (SITC) Pan-tumor Harmonization of Pathologic...

Right ventricle (RV) dysfunction is associated with poorer outcomes in heart failure with preserved ejection fraction (HFpEF). Females are more likely to have HFpEF but males have worse prognosis and resting RV function. The contribution of dynamic RV-pulmonary artery (RV-PA) coupling between sex and its impact on peak exercise capacity (VO2) in HFpEF is not known.

A Phase I, single-center investigation demonstrated that 8 weeks of antimycobacterial therapy improved sarcoidosis forced vital capacity (FVC). Safety and efficacy assessments have not been performed in a multicenter cohort.

All aspects of medical education were affected by the Novel Coronavirus Infectious Disease-19 (COVID-19) pandemic. Several challenges were experienced by trainees and programs alike due to the economic repercussions of the pandemic, how social distancing affected the delivery of medical education, testing and interviewing, how the surge of patients affected redeployment of personnel, potential compromise in core training and the overall impact on the wellness and mental health of trainees and educators.

In this meta-analysis of observational studies, RV dysfunction was associated with higher short-term and long-term mortality in sepsis and septic shock.

Legionella is an uncommon cause of CAP, occurring primarily from late spring through early autumn. Testing is uncommon, even among patients with risk factors, and many positive patients failed to receive empiric coverage for LP.

The nS classification could be used to provide a more accurate prognosis in patients with resected NSCLC. The nS is worth taking into consideration when defining nodal category in the forthcoming ninth edition of the staging system.

NLP successfully identified a large cohort with CC. Most patients were identified through NLP alone, rather than diagnoses or medications. NLP improved detection of patients nearly seven-fold, addressing the gap in ability to identify and characterize CC disease burden. Nearly all cases appeared to be managed in primary care. Identifying these patients is important for characterizing treatment and unmet needs.

Pulmonary arterial hypertension (PAH) is a rare disease and much of our understanding stems from single-center studies, which are limited by sample size and generalizability. Administrative data offer an appealing opportunity to inform clinical, research, and quality improvement efforts for PAH. Yet, there is currently no standardized, validated method to distinguish PAH from other subgroups of pulmonary hypertension (PH) within this data source.

A transparent DL algorithm improves on traditional clinical criteria to predict the need for MV in hospitalized patients, including in those with COVID-19. Such an algorithm may help clinicians optimize timing of tracheal intubation, better allocate resources and staff, and improve patient care.

To assess airway and lung parenchymal damage non-invasively in cystic fibrosis (CF), chest MRI has been historically out of the scope of routine clinical imaging due to technical difficulties such as the low proton density and respiratory and cardiac motion. However, technological breakthroughs have recently emerged to dramatically improve lung MRI quality (including signal-to-noise ratio, resolution, speed, contrast). At the same time, novel treatments have changed the landscape of CF clinical care.

Bronchoscopic lung volume reduction with one-way endobronchial valves is a guideline treatment option for patients with advanced emphysema, supported by extensive scientific data. Patients limited by severe hyperinflation, with a suitable emphysema treatment target lobe and with absence of collateral ventilation are the responders to this treatment. Detailed patient selection, a professional treatment performance, and dedicated follow-up of the valve treatment, including management of complications, are key ingredients to success.

Chronic Obstructive Pulmonary Disease (COPD) may cause profound dyspnea, functional impairment, and reduced quality of life. Available pharmacologic therapy provides suboptimal symptom improvement in many patients. Bronchoscopic lung volume reduction (BLVR), achieved with endobronchial valve (EBV) placement, can effectively improve dyspnea and functional status in appropriately selected patients. Operationalizing a safe and effective BLVR program requires appropriate oversight which can be achieved by a BLVR Nurse Coordinator (NC).

Empathy-based, stigma-reducing communication may lead to improved assessments of tobacco use and smoking cessation for patients with smoking-related cancers. These findings support the dissemination and further testing of a new ECS model for training OCPs in best practices for assessment of smoking history and engagement of patients who currently smoke in tobacco treatment delivery.

In clinical practice, reslizumab may have been initiated in response to heavy symptom burden and CAEs. Reslizumab was associated with improved clinical and patient-reported outcomes and significant reductions in asthma-related HRU.

Quantitative emphysema measured on LDCT of the chest can be leveraged to improve lung cancer risk prediction and help diagnose COPD in individuals who currently or formerly smoked undergoing lung cancer screening.

CDK4/6 inhibition provides additional efficacy in HER2⁺, HR⁺ breast cancer

New epidemiological data from the American Cancer Society indicate a continued decline in overall cancer mortality in the USA but also reveal alarming countertrends. Rising advanced-stage presentation of prostate cancer, an accelerating incidence of early-onset colorectal cancer, and widening disparities in uterine and lung cancer outcomes underscore that the next frontier in oncology is equitable delivery, not just biological discovery.

First-line therapy for chronic lymphocytic leukaemia (CLL) is rapidly evolving, with a recent phase III trial showing that fixed-duration therapy with BCL-2 inhibitor-based doublet regimens is non-inferior to continuous BTK inhibitor therapy. Novel approaches to further improve outcomes with time-limited regimens include measurable residual disease-guided and three-drug approaches.

Sacituzumab govitecan plus pembrolizumab improves outcomes

Platelets can promote cancer progression through either direct and indirect mechanisms, and they can also suppress tumour progression in certain contexts. The authors of this Review discuss how insights on these properties have been leveraged to develop cancer therapies in which platelets are engineered to act as targeted delivery vehicles or as active effector cells, outlining opportunities and challenges for clinical translation.

Novel immunotherapy combinations are now available for second or later-line therapy for follicular lymphoma. The addition of tafasitamab, an anti-CD19 antibody, or epcoritamab, a CD20 × CD3 bispecific antibody, to lenalidomide–rituximab (R2) has demonstrated promising efficacy. Herein, I compare recent phase III trials testing each combination and discuss their practical implications.

Premenopausal women aged <40 years diagnosed with oestrogen receptor-positive early-stage breast cancer have disproportionately poorer outcomes relative to older women. The authors of this Review propose a biology-driven approach to challenge the conventional sequencing of chemotherapy and endocrine therapy in this population.

Anbenitamab is a new second-line option in G/GEJ adenocarcinoma

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The percentage of patients achieving total clearance of eczema lesions in a Phase 2b trial increased with prolonged rezpeg treatment.

The newly public Evommune shared data showing that EVO301, an IL-18 targeting protein, cleared symptoms comparably to Regeneron and Sanofi’s mega-blockbuster in a mid-stage atopic dermatitis clinical trial.

Kailera will launch a global Phase 2 study of ribupatide this year, while Hengrui will push the asset into Phase 3 in China.

According to Priovant, the Phase 2 BEACON study is the first industry-sponsored placebo-controlled trial in cutaneous sarcoidosis to deliver positive data.

With data from a mid-stage trial showing weight loss of up to 12.3% at 28 weeks in patients treated with PF’3944, “Pfizer is moving full speed into obesity clinical development,” BMO Capital Markets said Tuesday.

Arrowhead heralded the results as proof of concept that inhibiting the Activin E pathway can improve body composition and enhance weight loss as compared to tirzepatide alone, particularly in patients with type 2 diabetes.

One way Takeda lives out its values is by striving to ensure that patients are aware of and can access the company’s clinical trials. Two employees from its research and development organization discuss why representation matters and the work their team is doing to benefit patients now and in the future.

The major depressive disorder failure for BHV-7000 is the drug’s second, after Biohaven’s spinocerebellar ataxia treatment troriluzole was rejected by the FDA in November 2025.

Insmed pointed to a strong placebo response as the reason for the trial’s failure.

In a first for the Parkinson’s field, AC Immune’s immunotherapy has stabilized key biomarkers that suggest an effect on the disease’s course.

Evidence of durability of psilocybin-based COMP360 is a key point for the FDA, according to Compass Pathways Chief Medical Officer Guy Goodwin. By providing 26 weeks’ worth of such data instead of the requested 12, the company is delivering “in spades,” he said.

Following the successful late-stage study in wet age-related macular degeneration, Ocular plans to meet with the FDA to determine a regulatory path for Axpaxli.

Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.

Sanofi will take venglustat to regulators for Gaucher disease but an application for Fabry disease is less clear after the failure of a Phase III trial.

With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”

Corcept’s overall survival data “look competitive” with AbbVie’s Elahere and Merck’s blockbuster Keytruda, Truist Securities said Thursday.

The mixed data from the Phase III COAST 2 trial follows an underwhelming data drop from COAST 1 in September that Leerink Partners said “fell well below expectations.”

The companies have an expansive clinical program for the mRNA neoantigen therapy intismeran autogene in combination with immuno-oncology heavyweight Keytruda.

Despite the late-stage miss, analysts maintained confidence in the Epkinly program, with Truist Securities saying the result “doesn’t waver our optimism” regarding the bispecific antibody’s ongoing frontline trial.

Following rusfertide’s triumphant Phase III trial last year, Protagonist must decide how involved to be in future development. Hundreds of millions of dollars are on the line.

In this episode of Denatured, you’ll be listening to Jane Hughes, President of R&D and Co-founder of Verdiva Bio, and Jon Rees, CEO and Co-founder of MitoRx Therapeutics. We’ll discuss next-generation obesity solutions tackling GLP-1’s muscle loss and adherence challenges, through innovative muscle preservation, oral administration and combination therapy.

Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the protocol was developed with former FDA leaders.

Evidence of durability of psilocybin-based COMP360 is a key point for the FDA, according to Compass Pathways Chief Medical Officer Guy Goodwin. By providing 26 weeks’ worth of such data instead of the requested 12, the company is delivering “in spades,” he said.

Following the successful late-stage study in wet age-related macular degeneration, Ocular plans to meet with the FDA to determine a regulatory path for Axpaxli.

Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.

In this episode of Denatured, Jennifer C. Smith-Parker speaks with Dr. Rob Monroe and Jennifer Fakish at Danaher Corporation. They discuss how antibody drug conjugates (ADCs) are transforming cancer care. With AI-powered pathology, doctors can now measure HER2 more precisely to match patients with the best treatments.

The percentage of patients achieving total clearance of eczema lesions in a Phase 2b trial increased with prolonged rezpeg treatment.

After receiving a letter directly from CBER Director Vinay Prasad, Moderna said the FDA had previously signed off on the use of a licensed flu vaccine as a comparator for a Phase 3 study of mRNA-1010.

Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.

The newly public Evommune shared data showing that EVO301, an IL-18 targeting protein, cleared symptoms comparably to Regeneron and Sanofi’s mega-blockbuster in a mid-stage atopic dermatitis clinical trial.

On February 19, 2026, the Food and Drug Administration approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

On February 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.

On January 27, 2026, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

On December 17, 2025, the Food and Drug Administration approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab (Rybrevant, Janssen Biotech, Inc.). See the prescribing information for the specific indications.

On December 17, 2025, the Food and Drug Administration approved rucaparib (Rubraca, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx).

On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.

On December 12, 2025, the Food and Drug Administration approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as determined by an FDA-approved test.

On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy

On December 3, 2025, the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

On November 25, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).

On November 21, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin.

On November 19, 2025, the Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024.

On November 19, 2025, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

On November 19, 2025, the Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021.

On November 19, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication.

On November 18, 2025, the Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024). 

On November 13, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc.). This is the first approval of a biosimilar for Perjeta.

On November 13, 2025, the Food and Drug Administration approved ziftomenib (Komzifti, Kura Oncology, Inc.), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.

On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM).

On October 24, 2025, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.

On October 23, 2025, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

On October 2, 2025, the Food and Drug Administration approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals, Inc.) in combination with atezolizumab (Tecentriq, Genentech Inc.) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech Inc.) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.

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