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Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

In the ICU, a resident is surrounded by deaths, each one leaving him with a sense of emptiness. Then a Christmas tragedy highlights medicine’s privilege of bearing witness to love as well as death.

Among patients with multiple myeloma, 7-year overall survival with 2 years of lenalidomide therapy was similar to that with indefinite therapy. Adverse events and second cancers were more common with indefinite therapy.

Multiple myeloma has undergone a therapeutic revolution at a pace nearly unmatched in oncology. Yet amid these advances, a key assumption in multiple myeloma therapy persists: more and longer treatment is better. The trial by Kumar and colleagues (ENDURANCE), reported in this issue of the Journal,1 ...

This review summarizes platelet-activating anti–platelet factor 4 disorders, including heparin-induced thrombocytopenia and related syndromes, highlighting diagnosis, antibody mechanisms, and treatment strategies.

After total hip or knee arthroplasty, aspirin alone was noninferior to rivaroxaban followed by aspirin in preventing symptomatic venous thromboembolism, with a similarly low risk of bleeding complications.

A patient with type 1 diabetes received genetically modified allogeneic islets and no immunosuppression. Results obtained through 14 months support β-cell function and a lack of immune response against the allograft.

Among patients with resected ALK-positive non–small-cell lung cancer, 2-year disease-free survival was higher with the ALK inhibitor ensartinib than with placebo. Grade 3 adverse events were more frequent with ensartinib.

An ICU physician believed letting her father die at home meant comfort, dignity, control, family close by, and the quiet reassurance of hospice. But she didn’t realize what it would require of her family.

A 42-year-old man with a recent stem-cell transplant presented with a 2-week history of urinary frequency and weak stream. Papules were seen on the penile shaft. Urethroscopy showed papillomatous lesions on the urethral mucosa.

In patients with resected clear-cell renal-cell carcinoma, pembrolizumab plus belzutifan led to higher disease-free survival than pembrolizumab alone but an increased risk of grade 3 or higher adverse events.

Patients with shrinking cognitive bandwidth may feel their disability keenly in daily life, even if they can pass a controlled test of cognitive capacity. How should clinicians approach and care for them?

In a cluster-randomized trial involving patients having major noncardiac surgery, tranexamic acid reduced the need for red-cell transfusion during hospitalization and was noninferior to placebo for venous thromboembolism within 90 days.

Among 38 patients who received CAR T-cell therapy for refractory or relapsed B-cell lymphomas, lymphoma-free survival at 10 years was 32% for large B-cell lymphomas and 47% for follicular lymphoma.

Every year, many millions of surgical patients worldwide are unnecessarily exposed to a higher-than-necessary risk of blood transfusion because they do not receive a single dose of tranexamic acid just before the surgery. This failing is due not to a lack of high-quality scientific evidence on the overall safety, efficacy,...

The EPA has decided to stop considering the monetary value of public health benefits in federal rulemaking related to air pollution. This decision could have profound health consequences.

A rapid response to crizotinib after failure of chemotherapy in a patient with infantile fibrosarcoma with a TFG::MET fusion underscores the value of molecular profiling in atypical disease. This approach could enable limb sparing.

Among patients with traumatic hemorrhage, prehospital whole-blood transfusion was not superior to standard transfusion with red-cell and plasma components in reducing the risk of death or massive transfusion.

Among patients with moderate or severe PTS, the addition of endovascular therapy to standard care resulted in less severe PTS and better quality of life at 6 months than standard care alone but with a higher risk of bleeding.

Among patients with traumatic hemorrhage, prehospital transfusion of whole blood did not result in lower 30-day mortality than transfusion of plasma or red cells. Outcomes did not differ according to the storage age of blood.

This review of the evolving management of differentiated thyroid cancer highlights overdiagnosis of low-risk disease, dynamic risk stratification, active surveillance or ablation, targeted therapies, and active patient involvement.

Attending large scientific conferences can be an endurance test. The sunrise sessions, the multiple parallel tracks, the thousands of steps walking back-and-forth from one end of a convention centre to the other, and the evening receptions, all combined with meetings with colleagues, old and new. But occasionally, it becomes apparent that the conference in question is different, that something historic has happened. This year's American Society of Clinical Oncology (ASCO) annual meeting was one such occasion, evoking memories of other examples such as ASCO 2010 and the 2025 San Antonio Breast Cancer Symposium (SABCS).

The SUBITO trial, presented by Rianne L Seefat and colleagues in The Lancet Oncology,1 revisits the long-standing debate surrounding high-dose chemotherapy with autologous stem-cell rescue in patients with high-risk early breast cancer, exploring its potential role in the modern era of therapies targeted to homologous recombination-deficient (HRD) tumours.

Although oestrogen receptor, progesterone receptor, and HER2 receptor expression status help to tailor neoadjuvant systemic therapy regimens in patients with breast cancer, the response to treatment is arguably more prognostic than is receptor status itself. The amount of residual disease following neoadjuvant therapy, as calculated by the residual cancer burden index, correlates with disease recurrence independent of stage or receptor status.1 In patients with high risk of recurrence based on substantial residual disease, trials such as KATHERINE and CREATE-X provide data to support escalation of adjuvant systemic therapy, providing truly personalised medicine for patients with breast cancer.

A non-invasive diagnostic test that enables us to safely avoid an invasive test is valuable. Historically, an elevated prostate-specific antigen (PSA) was the primary driver for a prostate biopsy. This approach was refined as a result of multiple large trials demonstrating the benefit of an MRI-based triage system, with MRI generally increasing the detection of clinically significant prostate cancer while reducing prostate biopsies.1

In The Lancet Oncology, Frank A Giordano and colleagues report the outcome of the INTRAGO II trial, a randomised, phase 3 study investigating the benefit of radiotherapy dose intensification in 314 patients with glioblastoma. The authors must be congratulated for successfully completing a technically complex trial. The radiotherapy boost was given with an additional 30 Gy single dose of intraoperative radiation by use of low-energy x-rays emitting 50 kV photons to the resection cavity, in addition to standard-of-care chemoradiotherapy.

Pleural mesothelioma is an uncommon, asbestos-associated cancer. Unlike most primary tumours, which grow spherically, mesothelioma conforms to the complex shape of the pleural cavity. As the disease progresses, multifocal tumour nodules coalesce and thicken to produce a crescent-shaped rind encasing the lung. Tumour foci might invade into adjacent structures, with limited between-plane resolution on routine imaging. This morphological complexity, combined with a typical pleural surface area of around 4000 cm2, makes radiological quantification extremely challenging.

The National Cancer Plan for England, published in February, 2026, sets out ambitious plans for the future of cancer care in England over the next 10 years.1 Overlooked in the plan, however, is the need to align these plans with the legal commitment of the National Health Service (NHS) to developing an environmentally sustainable health-care system, reducing health care-associated greenhouse gas emissions to net zero by 2045.2 Many policies set out in the plan could contribute to achieving this goal—realising co-benefits for health and environment—but the potential environmental impacts of some proposals need careful evaluation before and during implementation.

Gil Shamai and colleagues1 have produced the most methodologically rigorous computational pathology model to date for recurrence-score estimation in hormone receptor-positive, HER2 (also known as ERBB2)-negative early breast cancer. Leveraging TAILORx randomised treatment assignments to show differential chemotherapy benefit by menopausal status—a distinction no previous computational pathology study has achieved—the model raises the bar for the field. The minimal calibration approach, requiring only 100 slides and no local genomic labels, addresses barriers to deployment in resource-limited settings.

We thank Koinis and colleagues for raising a concern worth clarifying, as other readers might share it. They describe the intermediate-risk population as the group in which stratification is most needed, and argue that our model adds little value there. This conflates two distinct concepts: intermediate clinical or genomic risk and intermediate artificial intelligence (AI) risk. Our AI model is, itself, a stratification tool that resolves subpopulations within the conventionally uncertain clinical and genomic groups, precisely where it is most needed.

Bastiaan M Privé and colleagues reported on the phase 2 trial BULLSEYE, which investigated prostate-specific membrane antigen (PSMA) radioligand therapy with [177Lu]Lu-prostate-specific membrane antigen-617 ([177Lu]Lu-PSMA-617) in patients with PSMA-expressing oligometastatic (≤5 metastases) hormone-sensitive prostate cancer (HSPC), in a setting of biochemically recurrent prostate cancer with a fast prostate-specific antigen (PSA) doubling time of less than 6 months.1 Patients were randomly assigned to 177Lu-PSMA-617 every 6 weeks for up to four cycles or to deferred androgen deprivation therapy (ADT) with active monitoring.

We thank Elif Hindié and colleagues for their thoughtful comments on our recent Article.1 Interest in higher linear energy transfer (LET) radiopharmaceuticals, such as terbium-161 (161Tb), has recently increased.2 161Tb resembles lutetium-177 (177Lu) in its decay but additionally emits low-energy conversion electrons and Auger electrons with high LET. These electrons could induce greater genotoxicity at the cellular level,3 raising the hypothesis that micrometastases could be more effectively treated, similar to proposed advantages of alpha-emitters.

We write as clinicians and cancer survivors who underwent prolonged chemotherapy for oesophageal cancer. Our experiences highlight how access to implantable venous access devices (chemotherapy ports) can shape treatment quality, adherence, and dignity. Although standard in high-income settings, these devices remain unavailable or unaffordable in low-income and middle-income countries (LMICs), revealing an overlooked inequity in cancer care infrastructure.

Al-Thani MBH, Subramanian M, Halabi N, et al. Qatar national cancer care and research: pioneering strategies for global health excellence. Lancet Oncol 2025; 26: e369–80—In this Series paper, the labels for figure 2A have been corrected so that Qatar is the red line and the USA is the blue line. These corrections have been made to the online version as of June 29, 2026.

Over the past 10 years, Philip Morris International (PMI; headquartered at Stamford, CT, USA), a tobacco company, has repeatedly stated its intention to deliver a smoke-free future. According to the PMI website, it is “actively accelerating the decline of cigarette smoking beyond what traditional tobacco control measures can achieve alone.” Nonetheless, a new international advertising drive featuring PMI's flagship brand Marlboro has prompted critics to question the company's commitment to ending sales of combustible cigarettes.

The Public Health Commission in Spain has approved the expansion of the national breast cancer screening programme to include women aged 45–74 years.

On May 26, 2026, the European Cancer Organisation published the European Cancer Screening Policy Index 2026; on May 27, 2026, the American Cancer Society updated its colorectal cancer screening guidance to include blood-based testing for some adults; and Indonesia added colorectal cancer screening to its National Free Health Checkup programme for people aged 45 years and older who are at high risk. These developments come as health systems are under pressure not only to detect cancer earlier, but to ensure that screening is organised, equitable, and followed by diagnosis and care.

To a standing ovation in the Plenary Session, Brian Wolpin (Dana-Farber Cancer Institute, Boston, MA, USA) on behalf of an international team of researchers presented remarkable data from the RASolute 302 phase 3 trial, which showed a doubling of overall survival for patients with metastatic pancreatic adenocarcinoma. Pancreatic cancer is notoriously difficult to treat, but oncogenic RAS mutations are typically seen in more than 90% of cases, offering a unique opportunity for therapy. Daraxonrasib is a new oral, RAS(ON) multiselective, tri-complex inhibitor of mutant and wild type RAS.

The French National Assembly, or the lower house of Parliament, has adopted a private member's bill on a first reading to scale down the amount of cancer-causing cadmium used in phosphate fertilisers in France, from 90 mg/kg to 20 mg/kg by 2030.

The UK Government has pledged £20 million to help improve prostate cancer research and treatment, including the expansion of a landmark screening trial to include all Black men who are eligible.

Campaigners say the USA will reach a “monumental” juncture in September, 2026, when a total of 14 jurisdictions will legally allow medical aid in dying (MAID) after laws in the states of New York and Illinois come into force.

The price of platinum-based cancer drugs in India has been raised in response to a nationwide shortage, following Government approval last week.

*Sachin R Jhawar, Jose G BazanDepartment of Radiation Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43212, USA (SRJ); Department of Radiation Oncology, City of Hope National Medical Center, Duarte, CA, USA (JGB)

Over 2 billion people currently reside in conflict-affected areas. For millions of people affected by cancer in these areas, disruptions in health services lead to treatment delays or interruptions and, ultimately, amenable deaths. That people should endure both conflict and avoidable cancer death is a double injustice our professional oaths oblige us to confront. The OncoCorridor initiative, led by OncoDaily and the Institute of Cancer and Crisis, aims to reduce avoidable deaths from people diagnosed with cancer in conflict-affected regions by establishing a global network that connects them with treatment centres worldwide.

Aumolertinib in combination with chemotherapy significantly improved progression-free survival. Although this regimen was associated with increased toxicity, the side-effects were managed with dose adjustment and supportive treatment aligned with clinical practice. Long-term follow-up is required to assess overall survival. The AENEAS2 study provides evidence to guide clinical practice regarding EGFR-TKIs and their combination use in treating patients with advanced EGFR-mutated NSCLC.

These data demonstrate that targeting HRD yields promising outcomes in stage III, HER2-negative, HRD breast cancer and that intensified chemotherapy with autologous stem cell rescue does not provide any advantage over state-of-the-art chemotherapy plus olaparib.

Tailoring locoregional radiotherapy in cT1–2N1 breast cancer (with ≤3 nodes at imaging) to the nodal response after primary systemic therapy resulted in a low 10-year locoregional recurrence rate, with promising recurrence-free interval and overall survival. By (partially) omitting radiotherapy based on nodal response after primary systemic treatment, possible morbidity caused by the radiotherapy can be avoided, which could improve patients’ quality of life.

Breast cancer mortality at 20 years was significantly lower in the IM-MS irradiation group, whereas non-breast cancer mortality was numerically higher in the IM-MS irradiation group after 15 years, resulting in no long-term benefit of IM-MS irradiation on overall survival. Our results emphasise the importance of very long-term follow-up and advanced irradiation techniques to reduce the dose to organs of interest.

The ARTO trial showed significant benefit in overall survival with the addition of MDT to systemic therapy versus systemic therapy alone.

[68Ga]Ga-PSMA-11 PET-CT could have the potential to improve the diagnostic pathway of patients with a high clinical risk but non-suspicious or equivocal prostate MRI. Further research, including health-economic analyses and validation with other PSMA radiopharmaceuticals, are needed to confirm the clinical implementation and generalisability of this approach.

Perioperative systemic therapy cannot be recommended in all patients with resectable colorectal peritoneal-only metastases.

Instant, spatially precise dose escalation with intraoperative radiotherapy added to standard of care did not improve outcomes, questioning the value of further local dose intensification in resectable glioblastoma.

ARTIMES-based progression-free survival improves prognostic stratification and shows better trial-level surrogacy for overall survival compared with mRECIST-based progression-free survival. Pending prospective validation, ARTIMES could potentially facilitate a more reliable response evaluation in pleural mesothelioma.

The toxicity profile of T cell-engaging bispecific antibodies varies substantially across cancer types and antibody classes. This meta-analysis provides a comprehensive overview of treatment-related adverse event incidence and patterns, offering a valuable reference for optimising patient management in clinical practice.

Triple-negative breast cancer—the most aggressive breast cancer subtype—has a high propensity for brain metastases, with limited treatments and poor prognosis. The blood–brain barrier, long viewed as an impermeable therapeutic sanctuary, is the core barrier to effective care. This Review advocates a key paradigm shift for clinical and translational research: from merely circumventing the blood–brain barrier to actively targeting and exploiting its biology. We delineate triple-negative breast cancer-specific mechanisms of blood–brain barrier breach and evaluate emerging therapies via a clinically actionable three-pillar framework: physical and focal blood–brain barrier disruption, biological blood–brain barrier exploitation, and microenvironmental modulation.

Imaging is central to diagnosing, staging, evaluating treatment response, and guiding post-therapy surveillance in osteosarcoma and Ewing sarcoma, yet no international consensus defines optimal modalities or schedules. This European guideline, developed by 36 multidisciplinary experts, seeks to standardise imaging for research and enhance patient care. A systematic review identified 2026 studies, of which 13 met criteria, revealing marked heterogeneity in diagnoses, chemotherapy regimens, and imaging protocols.

Reirradiation can be considered for some patients with recurrent or second primary head and neck squamous cell carcinoma arising within previously irradiated regions, a clinical scenario associated with few therapeutic options. The increasing use of modern conformal radiotherapy techniques, including intensity-modulated radiotherapy, proton therapy, and stereotactic body radiotherapy, has expanded the feasibility of reirradiation in clinical practice. However, evidence remains heterogeneous, and clinical choices are challenged by substantial variability in patient presentation, previous treatments, and toxicity risk.

In the current era of QUAD + ASCT, the definition of FHR MM should encompass patients who have MM with disease progression in the first 36 months of therapy. This study provides benchmark data for clinical trials deploying agents with novel mechanisms of action in this difficult‐to‐treat population (ClinicalTrtials.gov identifier NCT03224507).

Different presentation phenotypes exhibit distinct clinicopathologic characteristics and have prognostic impact in ES‐HL. Further studies integrating molecular profiling are warranted to elucidate root mechanisms and possibly refine risk group allocation.

Real‐world data indicate that imatinib achieves comparable response rates to newer TKIs, with durable survival. Nilotinib consistently shows faster BCR‐ABL1 decline and improved EFS overall, consistent with prior network meta‐analyses. Lack of improvement in OS over time suggests the need to investigate factors influencing long‐term outcomes in CML.

Breast cancer screening is higher in civically engaged adults. More research is needed to understand the social mechanisms that underlie this relationship, but the findings support efforts to advance cancer control through paired public health and civic health programming.

Neighborhood socioeconomic disadvantage may contribute to cognitive vulnerability before cancer treatment. However, these findings suggest that years of education and depressive symptoms should be factored into the consideration of neighborhood‐level factors when assessing CRCI risk among women with breast cancer (Clinicaltrials.gov identifier NCT02793921).

Novel findings from this statistically rigorous analysis of a large patient population include: identifying genes of interest in osteosarcoma that are more often altered when compared to other cancers; identifying MYC and CCND3 amplification as significantly more prevalent in osteosarcoma diagnosed in childhood; and proving mutual exclusivity and co‐occurrence with statistical robustness.

As in previous studies, patients treated with chemotherapy after immunotherapy failure had poor outcomes, similar to those from pre‐immunotherapy era, and should be used when no other options are available.

Disparities in cervical and breast cancer screening persist among SOGI minorities. These findings underscore prevalent structural and systemic barriers in preventive cancer care and highlight the need for inclusive, culturally sensitive interventions to promote equitable screening access.

No differences in late mortality, SMNs, and most CHCs were observed between patients who received VDC versus VDC/IE. Aging EWS survivors’ elevated risk of morbidity and mortality underscores the need for lifelong survivorship care and therapies that reduce the risk for late effects.

This cohort study investigates tumor-infiltrating clonal hematopoiesis in solid tumors and evaluates its association with clinical factors and overall survival.

This cohort study characterizes the prevalence of treatment for metastatic non–small cell lung cancer and predictors of its receipt over a time span ranging from when empiric cytotoxic regimens dominated to the recent availability of targeted therapies and immunotherapy.

This cohort study investigates whether the potential association of modifiable risk factors with prostate cancer varies across genetic risk profiles and age.

This cross-sectional study investigates treatment delays in patients with early age–onset colorectal cancer and determines targetable factors contributing to delayed therapy.

This randomized clinical trial examines whether adding intraperitoneal paclitaxel to intravenous paclitaxel plus S-1 improves overall survival in gastric cancer with peritoneal metastasis.

This cohort study analyzes longitudinal rates of and factors associated with suicidal self-directed violence among veterans with cancer.

This meta-analysis compares survival with programmed cell death 1 protein or programmed cell death 1 ligand 1 (PD-[L]1) inhibitor monotherapy vs chemoimmunotherapy in treatment-naive patients with advanced NSCLC and high PD-L1 expression.

This descriptive surveillance study examines the percentage of lung cancer cases diagnosed at an early stage, visualizing temporal patterns with heat maps.

This decision analytical model study evaluates the effects of relabeling grade group 1 prostate cancer on prostate cancer mortality in the US.

This cohort study examines the association between prostate-specific membrane antigen positron emission tomography use and initial prostate cancer treatment.

This review examines the clinical utility of circulating tumor DNA assays for detecting minimal residual disease in patients with early-stage breast cancer.

This Viewpoint discusses concerns with the current grading of cutaneous toxic effects in Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 and proposes an updated framework.

This essay discusses the author’s experience as a physician in Beirut during wartime.

As of June 3, WHO Director-General Tedros Ghebreyesus reported 344 confirmed cases of Ebola virus disease in DR Congo, as well as 15 confirmed cases in Uganda. Encouragingly, suspected cases in the DR Congo have fallen, as efforts continue to eliminate delays in testing. However, this outbreak, caused by Bundibugyo virus (Orthoebolavirus bundibugyoense), highlights a recurring vulnerability in epidemic preparedness: limited access to reliable and accurate diagnostics and absence of specific treatments and vaccines.

For decades, paediatric anticoagulation has been guided more by extrapolation than by evidence. Treatments for venous thromboembolism in children have largely mirrored adult practice, despite fundamental developmental differences in haemostasis and drug handling. The emergence of direct oral anticoagulants (DOACs) marks a turning point, with the first generation of trials specifically designed for paediatric populations published in the past 5 years. Within this context, the study by Leonardo R Brandão and colleagues1 provides timely and important data on apixaban in children with venous thromboembolism.

Edel Y, Stein PE, Kawtharany H, et al. Guidelines for the management of acute porphyria: recommendations from the International Porphyria Network. Lancet Haematol 2026; 13: e338–50—In this Review, the list of countries in the first paragraph of the Methods section should contain Norway and not Denmark. This change has been made on May 27, 2026.

Donzel M, Khedimallah S, Barriere S, et al. Prediction of bone marrow fibrosis from complete blood count in myeloproliferative neoplasms (FIBOM-AI): a multicentre machine learning model development and validation study. Lancet Haematol 2026; 13: e396–407—In this Article, Agathe Gouband and Damien Luque Paz's affiliation should have been “Univ Angers, Nantes Université, CHU Angers, Inserm, CNRS, CRCI2NA, Angers, France”, and their degrees should have been PharmD. In addition, the acknowledgments should read “We thank the FIMBANK network, funded by the French Institut National du Cancer (INCa BCB 2013 & 2022), for providing data for some of the patients included in the present study.” These corrections have been made to the online version as of July 2, 2026.

In 2025, the European Medicines Agency and the Heads of Medicines Agencies issued recommendations to address vulnerabilities in the supply of anti-RhD immunoglobulin (RHIG; used to prevent RhD alloimmunisation during pregnancy). This alert highlights a broader but under-recognised problem: the fragile global supply of hyperimmune immunoglobulins, a group of plasma-derived medicines essential for post-exposure prophylaxis (PEP) and maternal–child health. Despite their various inclusions in the WHO Model Lists of Essential Medicines for adults and children and in national lists, these products remain vulnerable to shortages and fragmented procurement in both high-income countries (HICs) and low-income and middle-income countries (LMICs).

With its museums, art galleries, and a castle that dominates the skyline, it is little wonder that Edinburgh, UK, is ranked regularly among the most popular global destinations for tourists. Yet if visitors look beyond the most famous attractions—such as the Palace of Holyroodhouse, the Royal Yacht Britannia, and the Royal Botanic Garden—then Scotland's capital city boasts a plethora of destinations that lie off the beaten track. One of those hidden gems is the Physicians’ Gallery on Queen Street, a free museum in which the Royal College of Physicians of Edinburgh (RCPE) hosts exhibitions drawn from its library of more than 85 000 books, journals, pamphlets, and other items, supplemented with exhibits borrowed from other collections.

Fixed-duration epcoritamab monotherapy showed promising complete response rates and a manageable safety profile in older adults with newly diagnosed DLBCL and comorbidities, with slight differences between stages 1 and 2. Continued investigation of epcoritamab as a first-line chemotherapy-free treatment option is warranted.

Inotuzumab ozogamicin showed high activity as reinduction treatment in paediatric very high risk first B-cell acute lymphoblastic leukaemia relapse and a favourable toxicity profile with no treatment-related deaths.

Our findings could assist clinicians in delivering more targeted and timely supportive care interventions and might inform patients about anticipated symptoms during the early post-CAR T-cell infusion period. Moreover, the observed discrepancies between patient-reported and clinician-reported symptoms suggest that more systematic use of patient-reported outcome measures might provide complementary insights beyond those captured through clinician assessment.

In this descriptive study, the safety and efficacy profile of a fixed-dose-by-bodyweight-tier apixaban regimen was similar to that of standard of care for the treatment of venous thromboembolism and prevention of venous thromboembolism recurrence in children younger than 18 years, providing a potential additional treatment option in this patient population.

The European Group for Blood and Bone Marrow transplantation Practice Harmonization and Guidelines Committee together with the Lymphoma Working Party convened 23 experts in Hodgkin lymphoma, transplantation, and radiation oncology, to develop consensus recommendations on the use of autologous and allogeneic haematopoietic cell transplantation (HCT) in relapsed or refractory Hodgkin lymphoma. Through a structured literature review and a 2-day workshop in Berlin, Germany, on Sept 29 and 30, 2025, the panel established guidance across major clinical decision points.

Haematologists should be prepared to address several key transitions and timepoints during the female reproductive health lifespan to provide safe and equitable care for all patients with haematological disorders. In this Review, we summarise important points for recognition and consideration in the care of patients with lifelong or transient haematological conditions. We include discussions on menarche, pregnancy, menopause, and gender-affirming care, and how these life transitions might impact people with underlying haematological disorders, including an increased risk of iron deficiency with or without anaemia.

The inpatient classical haematology consult service occupies a specialised, complex, and high-acuity domain in the hospital setting. As three academic classical haematologists practicing primarily or exclusively as inpatient consultants in the US, we describe the wide spectrum of haematological disorders we manage in our practices and the rapidly expanding number and complexity of treatments we have to offer, therefore necessitating a substantial breadth and depth of diagnostic and therapeutic expertise to practice successfully in this setting.

A 25-year-old construction worker with a history of marijuana and cocaine use presented with 3 months of weight loss, fever, night sweats, cough, and progressive dyspnoea. He was transferred to Hospital Alma Mater de Antioquia (Medellín, Colombia) on Nov 20, 2025, after developing haemodynamic instability and worsening hypoxaemia, despite treatment with broad-spectrum antibiotics. Imaging showed a left pleural effusion with lower-lobe atelectasis, generalised lymphadenopathy, and hepatosplenomegaly.

The use of IV iron in clinical practice has increased significantly in recent years. In this Plenary Paper, Wagner and colleagues demonstrate that ferric carboxymaltose (FCM) is associated with a higher risk of fractures than ferric derisomaltose and show that FCM impairs bone recovery in mouse models despite correction of anemia. Mechanistically, FCM preferentially accumulates in bone, suppresses collagen production and bone formation pathways, alters dentin matrix protein 1–integrin signaling, and sustains elevated fibroblast growth factor 23 levels, suggesting that its skeletal toxicity extends beyond the well-recognized effects of hypophosphatemia. These findings support consideration of alternative IV iron formulations that provide similar efficacy without risk of skeletal complications.

Hairy cell leukemia (HCL) and HCL variant (HCLv) are uncommon chronic B-cell neoplasms that share several clinical and pathological features but differ substantially in their molecular drivers, clinical course, and therapeutic approach. Zent and colleagues present consensus guidelines that offer clinicians an updated overview of current approaches to diagnosing and managing patients with HCL and HCLv, along with perspectives on emerging targeted therapies aimed at improving outcomes.

Mora and colleagues have improved the existing myelofibrosis secondary to polycythemia vera and essential thrombocythemia prognostic model (MYSEC-PM) for secondary myelofibrosis by incorporating molecular and cytogenetic data, creating the mutation-enhanced MYSEC-mPM and the karyotype- and mutation-enhanced MYSEC-kmPM. By analyzing 644 patients, they identified mutations in ASXL1, U2AF1, TP53, and SRSF2, as well as complex or monosomal karyotypes, as independent predictors of poor survival, significantly improving risk stratification beyond clinical factors alone. These updated models provide more precise survival prediction that may better guide transplant decisions, patient monitoring, and clinical trial design.

Kaulen and colleagues from the International Primary CNS Lymphoma (PCNSL) Collaborative Group (IPCG) developed the IPCG ID-PCNSL prognostic score for immunodeficiency-associated PCNSL, demonstrating its ability to stratify outcomes across patients with HIV infection, solid organ transplantation, or autoimmune disorders. Their analysis highlights the biological and clinical distinctiveness of Epstein-Barr virus–driven PCNSL in immunocompromised patients, while showing that survival remains poor for high-risk groups despite widespread use of immune restoration strategies and rituximab- and high-dose methotrexate–based therapies. The study establishes the IPCG ID-PCNSL score as a practical tool for risk-adapted treatment decisions.

Induction therapy for pediatric acute myeloid leukemia (AML) is highly intensive and carries significant risks of toxicity. Gao and colleagues report results from the phase 3 CALS III-AML18 trial, showing that low-dose induction chemotherapy with granulocyte colony-stimulating factor achieves remission rates and survival outcomes comparable to those with standard-dose induction therapy in children with AML. This low-dose regimen is associated with fewer toxicities, faster hematologic recovery, and reduced health care costs, suggesting a feasible treatment strategy for resource-limited settings. Further validation of this chemotherapy deescalation regimen is needed for optimization of low-dose approaches.

Lysine acetyltransferases (KATs) are chromatin modifiers that facilitate transcriptional activation. Meyerhöfer and colleagues demonstrate that pharmacologic inhibition of the KAT activity of p300/CREBBP unexpectedly activates interferon-stimulated genes in acute myeloid leukemia (AML) cells by increasing p300/CREBBP occupancy at interferon-responsive regulatory elements and promoting STAT1-mediated transcription. This transcriptional rewiring sensitized AML cells to interferon alpha, increased apoptosis, and reduced leukemia burden in both in vitro and in vivo models. Further preclinical evaluation is needed to understand the translational implications of these findings.

One of the major challenges in heparin-induced thrombocytopenia (HIT) diagnosis is differentiating between pathogenic and nonpathogenic anti–heparin/platelet factor 4 (PF4) antibodies. Bissola and colleagues developed engineered single-chain variable fragment (scFv) inhibitors derived from a HIT-like monoclonal antibody to selectively target pathogenic heparin/PF4 antibody epitopes and improve diagnostic discrimination in HIT. The incorporation of these scFvs into enzyme immunoassays increased specificity and improved assay accuracy in a small patient cohort. Further analytical and clinical validation in larger cohorts is required before clinical implementation.

In this study, Zhou et al show that some platelet-activating anti–platelet factor 4 (PF4) antibodies in heparin-induced thrombocytopenia (HIT) are not detected by standard PF4/heparin enzyme-linked immunosorbent assays (ELISAs). These ELISA-negative antibodies can still strongly activate platelets through FcγRIIA-dependent mechanisms and contribute substantially to pathogenic activity, reflecting context-dependent antigen recognition of PF4 complexes. Although these findings highlight limitations of current immunoassays, ELISA-negative functional antibodies appear uncommon in routine practice, reinforcing the continued importance of integrating clinical scoring with both immunoassays and functional platelet activation testing.

Steroid-refractory acute graft-versus-host disease (aGvHD) remains a major clinical challenge after allogeneic hematopoietic stem cell transplantation. Pan and colleagues investigated biomarkers that identify patients with newly developed aGvHD destined to become steroid refractory. Expansion of activated CD28⁺ CD8⁺ effector-memory T (Tem) cells was associated with steroid-refractory disease and linked to a proinflammatory, STAT1-driven reduction in glucocorticoid receptor expression. They further show that JAK/STAT inhibition with ruxolitinib can reverse these changes and restore steroid sensitivity, suggesting a potential strategy for early or preemptive treatment of high-risk patients.

As reported in The Lancet Oncology by Siva et al, long-term outcomes of an Australian-Dutch phase II study (TROG 15.03 FASTRACK II) support the safety and local disease control seen with stereotactic ablative body radiotherapy (SABR) in patients with primary renal cell carcinoma who did not undergo ...

In the long-term follow-up of a Japanese phase II/III trial (JCOG1008) reported in the Journal of Clinical Oncology, Tahara et al found maintained noninferiority of chemoradiotherapy with weekly vs every-3-week cisplatin for overall survival in patients with postoperative high-risk locally advanced ...

Results of the phase III EMERALD-3 trial showed that combining transarterial chemoembolization (TACE) with the immunotherapy-based STRIDE regimen, (single tremelimumab[an anti-cytotoxic T lymphocyte–associated antigen 4] plus regular interval durvalumab [anti–PD-L1]) with or without lenvatinib...

A vaccine targeting common KRAS mutations was safe and stimulated KRAS-specific T-cell responses in 90% of study participants who were at high risk of developing pancreatic ductal adenocarcinoma (PDAC), according to phase I clinical trial results published by Haidar et al in Cancer Discovery.

Findings from a National Health Interview Survey revealed that civically engaged adults were more likely to stay up to date with their breast cancer screenings. The research findings were published in the American Cancer Society's Cancer journal. 

Based on the results of a population-based, descriptive, cross-sectional study published in JAMA Network Open by Gomez et al, invasive breast cancer incidence rates accelerated among Asian American, Native Hawaiian, and Pacific Islander women over 2 decades.

Oral nicotinamide (vitamin B3) may provide a cost-effective strategy for preventing keratinocyte carcinoma (KC) in persons at high risk, according to a study published in JAMA Dermatology. Led by David Perez, BA, the study was designed to determine whether the clinical benefits previously observed...

In a meta-analysis published in The Oncologist, researchers found that second-generation Bruton's tyrosine kinase (BTK) inhibitors had a better cardiovascular safety profile than the first-generation BTK inhibitor ibrutinib for patients with B-cell malignancies. This led to fewer reported key...

Circulating tumor DNA (ctDNA) for molecular residual disease tracking could help identify patients with colorectal cancer and liver metastases who are most likely to benefit from adjuvant chemotherapy after surgery, according to findings from an overall survival analysis of the phase II GALAXY...

Researchers have created a comprehensive single-cell map of the tumor immune microenvironment in multiple myeloma and its precursor conditions. The newly published findings provide insights that may explain why patients with similar diagnoses often have differences in disease progression, treatment ...

According to a diagnostic study reported in JAMA Dermatology by Anriot et al, a modern artificial intelligence (AI) foundation model outperformed less experienced clinicians but did not match the diagnostic performance of expert dermatologists when tested under realistic clinical conditions. The...

As reported in The Lancet Oncology by Kaidar-Person et al, an unplanned subset analysis at 20 years in the phase III EORTC trial 22922/10925 showed that internal mammary and medial supraclavicular (IM-MS) nodal irradiation was associated with a significantly lower rate of breast cancer...

Virtual sustained counseling and nicotine replacement therapy led to an almost doubling of 6-month smoking quit rates compared with standard care for patients facing a recent cancer diagnosis, according to findings from the randomized controlled ECOG-ACRIN EAQ171CD trial from the National Cancer...

As reported in The Lancet by Lu et al, an interim analysis of the Chinese phase III HARMONi-6 trial showed that ivonescimab plus chemotherapy was associated with significantly improved overall survival vs tislelizumab plus chemotherapy in patients with previously untreated advanced squamous...

New results from an Alliance Foundation Trials (AFT) study reveal that a simple weekly electronic symptom check-in with the care team significantly improves the quality of life for individuals undergoing treatment for advanced cancer. Researchers found that the biggest improvements were seen among...

In a prospective, multicenter, nonrandomized patient-preference trial published in JAMA Network Open, interval salpingectomy with delayed oophorectomy (ISDO) was associated with less impairment in sexual function than risk-reducing salpingo-oophorectomy (RRSO) among premenopausal women at high risk ...

For patients with newly diagnosed multiple myeloma not undergoing an autologous stem cell transplant, indefinite lenalidomide maintenance resulted in more toxicity with no survival benefit from continuing treatment until disease progression compared with stopping after 2 years. Results from the...

Setmelanotide, a melanocortin-4 receptor agonist, significantly reduced body mass index (BMI) and signs of hunger in patients with acquired hypothalamic obesity, according to findings from the phase III TRANSCEND trial published in The New England Journal of Medicine. Although focused primarily on...

As reported in The Lancet by Xiong et al, an interim analysis of a Chinese phase III trial (OptiTROP-Lung05) has shown that the addition of sacituzumab tirumotecan (a trophoblast cell–surface antigen 2–targeting antibody-drug conjugate) to pembrolizumab significantly prolonged progression-free...

In a study reported in the Journal of Clinical Oncology, Uppal et al identified factors associated with poorer outcomes in patients with TP53-mutated diffuse large B-cell lymphoma (DLBCL).

In the long-term follow-up to a phase II study published in The New England Journal of Medicine, Ruella et al found that a single infusion of the CD19-directed chimeric antigen receptor (CAR) T-cell therapy CTL019 (now called tisagenlecleucel) produced decade-long remissions in a subset of patients ...

An investigational targeted therapy designed to block one of the most common genetic drivers of pancreatic cancer has shown promising early results when combined with standard first-line chemotherapy, according to research presented at the ESMO Gastrointestinal Cancers Congress 2026 (Abstract...

More than 50 million Americans live in counties without a radiation oncology practice site and millions more are at risk, according to a new study published by Yu et al in the International Journal of Radiation Oncology • Biology • Physics (Red Journal). The national analysis found that from 2018...

In an analysis reported in the Journal of Clinical Oncology, Wilson et al found that prophylactic high-dose methotrexate does not provide significant benefit in reducing central nervous system (CNS) relapse in patients with ultra–high-risk large B-cell lymphoma (LBCL).

On July 14, the U.S. Food and Drug Administration (FDA) approved gedatolisib (Revtorpyk) in combination with fulvestrant, with or without palbociclib, for the treatment of adults with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA...

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.

Interim data from the phase III OptiTROP-Lung05 trial demonstrate that adding the TROP2-targeted antibody–drug conjugate sacituzumab tirumotecan to pembrolizumab improves progression-free survival in patients with PD-L1-positive advanced-stage non-small-cell lung cancer. Herein, I present several questions that need to be addressed before this combination can be considered a new standard of care, such as effect on overall survival, long-term safety, global generalizability and biomarker refinement.

Second-line ¹⁷⁷Lu-edotreotide shows promise in GEP NETs

Crossover in trials should not be viewed as confounding, but as informative. Crossover reveals whether deferring therapy produces outcomes comparable to those from earlier use. Statistical crossover-adjustment methods carry unaccounted biases and limited clinical utility. Crossover should instead guide treatment-sequencing decisions, weighing toxicity and cost against any overall survival benefit from earlier intervention.

The future of ciltacabtagene autoleucel in multiple myeloma has just begun

Ciltacabtagene autoleucel heralds the arrival of fixed-duration therapies in myeloma

CRISPR–Cas technologies provide a modular, programmable platform for sequence-specific targeting of DNA or RNA and have advanced from experimental molecular biology tools to clinical translation. This Review describes current and emerging applications of CRISPR–Cas platforms in oncology, including their use in discovery research, diagnostics and therapeutics.

Perioperative chemoimmunotherapy, comprising platinum-doublet chemotherapy plus an anti-PD-(L)1 antibody, has become the standard-of-care approach for patients with resectable non-small-cell lung cancer without an actionable driver alteration. However, the development of this approach has thus far been largely empirical, with limited capacity for adaptation of treatment strategies to better meet the needs of individual patients. In this Review, the authors discuss the potential for improvements in the current approach to perioperative therapy, including de-escalation for those with a pathological complete response, the capacity of various baseline and/or dynamic biomarkers to optimize outcomes, and the potential for escalation in patients with early evidence of a lack of responsiveness in the perioperative setting.

Modern oncology has built highly efficient pathways for patent-protected innovation, but no equivalent machinery for evaluating and developing promising off-patent therapeutics. Herein, we frame ‘open-source oncology’ as a parallel public-interest infrastructure to test, authorize and implement credible generic agents. Designed to translate ownerless evidence into standard-of-care treatments, this framework applies the same scientific seriousness devoted to proprietary drugs, decoupling clinical value from commercial ownership.

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Insmed’s inhalable candidate showed “impressive” long-term efficacy in pulmonary arterial hypertension, according to analysts at Guggenheim Partners, with functional and biomarker improvements through one year of follow-up.

New mid-stage data from Biogen’s Ionis-partnered therapy diranersen served to both validate the tau hypothesis in Alzheimer’s disease and raise questions that could soon be elucidated by anti-tau candidates from Denali Therapeutics, Eisai and Eli Lilly.

Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.

With the failure in chronic spontaneous urticaria, Evommune’s story is now centered on its anti-IL-18 therapy EVO301, Oppenheimer said, which in February elicited a 33% placebo-adjusted improvement in eczema severity.

A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.

Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.

Encouraging data for combination regimens of Revolution Medicines’ zoldonrasib “reinforce the path to leadership in PDAC” for the biotech, according to Truist Securities.

As uniQure prepares its closely watched Huntington’s disease gene therapy for FDA review, the biotech is also making waves in chronic epilepsy with another gene therapy that Stifel says is off to a “promising start.”

Backed by institutional investors and seasoned industry leaders, cAMPfield Therapeutics is advancing a clinical program aimed at reshaping the landscape for inflammatory bowel disease.

Following the mid-stage readout, Verastem Oncology has decided to move away from its investigational pancreatic cancer drug combo, instead putting resources behind its KRAS inhibitor pill for solid tumors.

Camlipixant, which GSK picked up in its $2 billion buyout of Bellus Health in April 2023, “is unlikely to transform patient care,” the pharma said.

The Phase 3 results are the first direct proof-of-concept for an ADC replacing platinum-based chemo in a first-line standard-of-care regimen for non-small cell lung cancer, according to Leerink Partners. The readout also represents the second late-stage win for the Merck and Kelun-Biotech asset, called sac-TMT.

Eli Lilly’s anti-amyloid Alzheimer’s drug is designed to be stopped after patients drop below a certain amyloid level in the brain. However, at the Alzheimer’s Association International Conference on Wednesday, Lilly revealed it is studying the potential of maintenance therapy for patients who need it.

GSK and Hansoh Pharmaceutical’s antibody-drug conjugate success validates their partnership, one of the many deals in which Big Pharma has tapped a China company for promising cancer candidates.

The late-stage miss is “surprising,” Stifel analysts said, given that Wainua’s mechanism of silencing transthyretin protein expression has previously proven effective.

New data on Hengrui Pharma and Kailera Therapeutics’ investigational oral GLP-1 have validated the late-stage weight loss asset and paved the road for a regulatory submission in China, but analysts pointed to high rates of nausea and vomiting that could challenge the ongoing U.S. study.

New data from a Phase 3 trial will further support a rolling submission for Compass Pathways’ psilocybin treatment COMP360. Patients who saw a clinically meaningful benefit on depression severity maintained response through week 26.

Patients treated with Bristol Myers Squibb’s Krazati in combination with cetuximab saw shorter median overall and progression-free survival than comparators on chemotherapy.

BridgeBio’s Attruby preserves kidney function in patients with transthyretin amyloidosis cardiomyopathy, an effect that is “distinct” from other drugs in this space, according to Jefferies.

Despite the late-stage fail, Vistagen will nevertheless continue to push its drug candidate forward and meet with the FDA to align on a potential registrational path.

With a Phase 3 failure denting the rare disease drug’s prospects, AstraZeneca has little room for error as it plots a path toward its ambitious 2030 sales target.

Agios Pharmaceuticals’ sickle cell disease candidate didn’t prove any better than Novo Nordisk’s investigational PK activator or the biopharma’s own asset that is currently under FDA review for the indication.

Camlipixant, which GSK picked up in its $2 billion buyout of Bellus Health in April 2023, “is unlikely to transform patient care,” the pharma said.

Insmed’s inhalable candidate showed “impressive” long-term efficacy in pulmonary arterial hypertension, according to analysts at Guggenheim Partners, with functional and biomarker improvements through one year of follow-up.

In this episode of Denatured, you’ll hear from Lance Alstodt, chairman and CEO at Biorestorative Therapies, and Paul Mieyal, chief business officer at South Rampart Pharma. We explore why pain has remained such a difficult therapeutic area to tackle and one of the biggest unmet needs today, and how non-opioid mechanisms to regenerative therapies could reshape the future of treatment.

The Phase 3 results are the first direct proof-of-concept for an ADC replacing platinum-based chemo in a first-line standard-of-care regimen for non-small cell lung cancer, according to Leerink Partners. The readout also represents the second late-stage win for the Merck and Kelun-Biotech asset, called sac-TMT.

Just weeks after Pfizer’s Seagen-acquired antibody-drug conjugate sigvotatug vedotin failed a Phase 3 non-small cell lung cancer study, the big pharma has quietly culled another program being developed by the ADC specialist.

New mid-stage data from Biogen’s Ionis-partnered therapy diranersen served to both validate the tau hypothesis in Alzheimer’s disease and raise questions that could soon be elucidated by anti-tau candidates from Denali Therapeutics, Eisai and Eli Lilly.

Eli Lilly’s anti-amyloid Alzheimer’s drug is designed to be stopped after patients drop below a certain amyloid level in the brain. However, at the Alzheimer’s Association International Conference on Wednesday, Lilly revealed it is studying the potential of maintenance therapy for patients who need it.

Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.

On July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

On July 14, 2026, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer (MIBC). This extends the prior approval for the regimen in this setting from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy.

On July 9, 2026, the Food and Drug Administration approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis U.S. LLC) for subcutaneous injection for multiple myeloma indications.

On June 30, 2026, the Food and Drug Administration approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell (HSPC) and T cells-vldq (Tregzi, Orca Bio) for use in matched donor hematopoietic stem cell transplantation (HSCT) with a myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (cGHVD)-free survival, in the treatment of adults with hematological malignancies.

On June 24, 2026, the Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for two indications in adults with triple-negative breast cancer (TNBC). 

On June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.

On June 12, 2026, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN-deficient as detected by an FDA-authorized test.

On June 12, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

On May 28, 2026, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).

On May 27, 2026, the Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

On May 22, 2026, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

On May 15, 2026, the Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo, Inc.) for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for T-DXd followed by a taxane, trastuzumab, and pertuzumab (THP), for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test. The second indication is for T-DXd for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (with or without pertuzumab) and taxane-based treatment.

On May 15, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc. and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) as adjuvant treatments for adults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test.

On May 13, 2026, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.

On May 13, 2026, the Food and Drug Administration granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

On May 8, 2026, the Food and Drug Administration approved zenocutuzumab-zbco (Bizengri, Partner Therapeutics, Inc.) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. NRG1-fusion positive cholangiocarcinoma is an extremely rare, life-threatening malignancy.

On May 1, 2026, the Food and Drug Administration approved vepdegestrant (Veppanu, Arvinas Operations, Inc.), a heterobifunctional protein degrader, for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. 

On March 25, 2026, the Food and Drug Administration approved relacorilant (Lifyorli, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.

On March 20, 2026, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL).

On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. 

On February 26, 2026, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for an expanded indication for adults with unresectable 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-authorized test.

On February 24, 2026, the Food and Drug Administration granted traditional approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-authorized test. Encorafenib received accelerated approval in combination with cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation in 2024. 

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).

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Yee AZH, Sng JRH

Acta Diabetol. 2026 May;63(5):775-785. doi: 10.1007/s00592-025-02607-y. Epub 2025 Nov 10.
Singh DR, Malviya S, Sundaram SM

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