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In a phase 3 trial in patients with persistent chemotherapy-induced thrombocytopenia, 84% of those receiving romiplostim had no chemotherapy dose modifications, as compared with 36% of those receiving placebo (odds ratio, 10.16).

In untreated chronic lymphocytic leukemia, fixed-duration venetoclax-based regimens were noninferior to continuous ibrutinib with regard to 3-year progression-free survival and were associated with higher MRD-negative rates.

The IARC Working Group summarizes guidance on H. pylori screen-and-treat programs for gastric cancer prevention and concludes that prevention is the most effective strategy amid a rising global burden.

The CMS Innovation Center is approaching the next negotiation cycle for the CGT Access Model. Several considerations will guide the selection of future candidate diseases and potential new model designs.

Myelosuppression has long been the major dose-limiting toxic effect of chemotherapy in treating cancer. Reducing the severity of chemotherapy-induced myelosuppression addresses two priorities. One is to prevent myelosuppressive complications — neutropenia and thrombocytopenia, in particular — that can lead to febrile neutropenia, infection, and bleeding. A second priority centers around...

A 49-year-old woman presented with a 6-month history of an itchy lump on her vulva. Examination showed a painless purple mass originating in the labia minora on the left side.

Neoadjuvant gemcitabine–oxaliplatin, lenvatinib, and anti–PD-1 antibody led to longer event-free survival than surgery alone in resectable high-risk intrahepatic cholangiocarcinoma, with mainly low-grade adverse events.

This review summarizes advances in radiotherapy that reduce injury to normal tissue, including improvements in the precision of imaging and delivery, and outlines strategies to prevent and manage treatment-related side effects.

A CD19-targeted therapy induced remission in a woman with refractory immune thrombocytopenia and antiphospholipid syndrome by stabilizing platelet counts, eliminating pathogenic antibodies, and enabling safer long-term anticoagulation.

In a phase 1 study of the oral p53 reactivator rezatapopt in heavily pretreated patients with TP53 Y220C–mutated solid tumors, the most common adverse events were nausea and vomiting, and the overall response was 20%.

In patients with HER2-positive early breast cancer and residual disease after neoadjuvant therapy, trastuzumab deruxtecan improved invasive disease–free survival but carried a risk of interstitial lung disease.

When a physician’s own incidental finding sends her down a long and winding path to find answers, she finds herself overcome with worry — but also, eventually, a new appreciation for life.

Recent FDA actions related to leucovorin have caused confusion. There is still a lack of scientific evidence establishing that the drug is a safe and effective treatment for autism.

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.

The author describes the scientific foundations of a study of rezatapopt, which targets a variant form of p53, to treat patients with solid tumors.

Over the course of the past three decades, human epidermal growth factor receptor 2 (HER2)–targeted treatment has dramatically transformed outcomes for patients with HER2-positive breast cancer across both early- and late-stage disease. HER2 has also emerged as a clinically meaningful biomarker in several tumor types, with HER2-targeted therapies showing substantial...

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...

On Feb 4, 2026—World Cancer Day—the long-overdue National Cancer Plan for England was finally published. The plan sets ambitious targets, promising that three quarters of all patients diagnosed with cancer will survive at least 5 years and that the UK will become a global leader in cancer survival by 2035. However, the feasibility of these ambitions is doubtful. The UK's current 5-year survival is among the lowest of all high-income countries, and internal reviews have presented the National Health Service (NHS) as broken.

The Lancet Oncology Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) study on global breast cancer burden provides comprehensive epidemiological trends from 1990 to 2023, with projections to 2050.1 According to this study, breast cancer was the most diagnosed cancer up until 2023.2 Although this ambitious undertaking addresses crucial needs in global oncology, several methodological concerns warrant attention before these estimates inform policy decisions and resource allocation.

The therapeutic landscape of early-stage HER2-positive breast cancer has been transformed over the past two decades.1 The introduction of HER2-directed therapy, including the antibody trastuzumab, has fundamentally altered the natural history of this disease, converting an aggressive breast cancer subtype associated with poor outcomes into one with high rates of pathological complete response and excellent long-term survival.1,2 These gains were initially achieved using intensive multi-agent regimens incorporating HER2-directed therapies with anthracyclines, taxanes, and platinum chemotherapy in both the adjuvant and neoadjuvant settings.

Metastatic uveal melanoma is a rare and life-threatening cancer with limited treatment options. A characteristic feature of uveal melanoma is its strong liver tropism, resulting in liver metastases in approximately 90% of patients who develop metastatic disease. This distinct pattern has led to investigations of liver-directed therapeutic strategies in patients with uveal melanoma.

Timo F W Soeterik and colleagues1 are to be congratulated for their important contribution to guiding personalised treatment in patients with oligorecurrent prostate cancer, published in The Lancet Oncology. In this multicentre retrospective analysis, the authors curated a cohort of more than 500 men with metachronous oligometastatic prostate cancer who underwent prostate-specific membrane antigen (PSMA) PET for disease characterisation, followed by ablative radiotherapy to all sites of oligometastases.

20 years ago, the combination of radiotherapy with concomitant and adjuvant temozolomide, also known as the Stupp protocol,1 transformed glioblastoma treatment. It was the first multimodal regimen to show a survival advantage in newly diagnosed glioblastoma and is the standard of care two decades later. The trial1 identified a biomarker (MGMT) to predict benefit from temozolomide; yet this represents only the beginning of what biologically informed patient selection could achieve. Advances in single-cell profiling, spatial imaging, and systems immunology are revealing fundamental determinants of glioblastoma behaviour, including dynamic cell states, lineage plasticity, metabolic constraints, and the role of the brain's resident and infiltrating immune cells.

In December, 2025, the Trump administration announced completion of the second cycle of historic price negotiations between US Medicare and pharmaceutical manufacturers.1 Concurrently, it released plans to establish international reference pricing to lower the costs of cancer drugs and other medicines in Medicare to levels in peer countries.2 These policy changes could have important effects on access to cancer medicines globally.

I appreciate the excellent work by Natólia Alves and colleagues,1 comparing artificial intelligence (AI) and radiologists in pancreatic cancer detection using standard of care CT scans (PANORAMA study). The paper is a milestone in evaluating the real-world diagnostic performance of an AI system for the detection of pancreatic ductal adenocarcinoma (PDAC) on contrast-enhanced CT. This important advance will facilitate PDAC surveillance of individuals who are at high risk.2 However, PANORAMA study's AI system1 is not suitable for PDAC screening of people who are at average risk of PDAC and are asymptomatic.

We thank Hans Scherübl and Misha D P Luyer1 for their insightful comments on the PANORAMA study,2 regarding the challenges and opportunities of artificial intelligence (AI)-assisted detection of pancreatic ductal adenocarcinoma (PDAC), particularly in early-stage disease.

We congratulate Huiping Li and colleagues on the FABULOUS trial,1 which establishes fuzuloparib, with or without apatinib, as a viable option for HER2-negative metastatic breast cancer with germline BRCA1/2 mutations. As clinicians practising in a prefecture-level hospital in the Hunan province, we consider these findings from the perspective of accessibility and real-world applicability in resource-constrained settings.

We thank Ziran Qiu and Na Jin for their Correspondence regarding the FABULOUS trial1 and appreciate their practical perspectives.

We read with great interest the phase 2 KUNPENG trial by Yi-Long Wu and colleagues.1 The reported objective response rate of 48·8% with vebreltinib in MET amplification-driven non-small-cell lung cancer is promising. However, the use of a gene copy number (GCN) of six or higher as the sole enrolment criterion obscures crucial biological heterogeneity within this population. This methodological choice fundamentally limits the interpretability of the efficacy signal and poses a considerable risk for the design of the planned phase 3 trial.

We thank Yuxin Liu and colleagues for their interest in the KUNPENG study and concur that a clinically meaningful MET amplification cutoff is crucial to trial design and interpretation.1 Indeed, our selection of a gene copy number (GCN) of six or higher assessed by fluorescence in-situ hybridisation (FISH) was grounded in a biological rationale and clinical precedent. Mechanistically, MET amplification promotes oncogenesis through GCN gain-induced MET protein phosphorylation, and a GCN of six or higher confers a potent oncogenic driver function independent of hepatocyte growth factor.

The National Health Service (NHS) in England, UK, has set up the world's first national genetic cancer risk register to help track and screen individuals at higher risk of developing cancer and offer preventive and personalised care.

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.

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.

On Jan 27, 2026, Zimbabwe's Medicines Control Authority (MCAZ) alerted citizens about the circulation of an unauthorised formulation of goserelin acetate, a hormone therapy used in the treatment of prostate and breast cancer. It warned that the product could pose risks to patient safety. “Our records show that this product was not formally imported into Zimbabwe. The MCAZ cannot therefore ascertain the safety, quality and efficacy of this product”, the alert read.

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.

A coalition of 13 Democratic state attorney generals is urging the Trump administration to drop a “dangerous and scientifically unsupported” revision to a federal formaldehyde-inhalation risk assessment they say would put workers, consumers, and communities at risk of formaldehyde-linked cancers and asthma.

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 US Food and Drug Administration (FDA) has fast-tracked a promising new gene therapy, KB707, which is inhaled as a fine mist for the targeted treatment of advanced or metastatic non-small-cell lung cancer.

The Musée Curie, nestled in the historic heart of Paris near the Panthéon, offers a compelling journey through the extraordinary legacy of Marie and Pierre Curie—pioneers whose groundbreaking work in radioactivity transformed both science and medicine. As a dedicated centre for preserving and showcasing their contributions, the museum provides invaluable insights into the origins of radiological research and its profound impact on modern cancer therapies.

Earthquakes constitute major natural hazards, with the potential to cause extensive damage to infrastructure, substantial loss of life, and economic consequences. Türkiye is situated at the intersection of the Arabian and Eurasian tectonic plates and is traversed by both the North Anatolian and East Anatolian fault lines, resulting in high seismic activity across the region. In the last century, the country has experienced 16 major earthquakes with magnitudes of Mw 7·0 or higher. Among these earthquakes were the two major seismic events of 2023 (Mw 7·7 and Mw 7·6), which profoundly impacted southeastern Türkiye and northern Syria, resulting in more than 50 000 deaths and widespread structural destruction, including critical damage to health care facilities.

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.

The stable incidence and declining mortality rates of female breast cancer in high-income nations reflect success in screening, diagnosis, and treatment. In contrast, the concurrent rise in incidence and mortality in other regions signals health system deficits. Without effective interventions, many countries will fall short of the WHO Global Breast Cancer Initiative's ambitious target of achieving an annual reduction of 2·5% in age-standardised mortality rates by 2040. The mounting breast cancer burden, disproportionately affecting some of the world's most vulnerable populations, will further exacerbate health inequalities across the globe without decisive immediate action.

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.

Global access to brachytherapy remains profoundly unequal, with adequate coverage largely limited to HICs. Resource gaps are greatest in lower-income settings, where patients also travel farthest. Investment in new centres is urgently needed to reduce geographical and economic barriers to access.

MRI-guided optimisation of neoadjuvant chemotherapy duration was associated with favourable 3-year event-free survival outcomes in patients with stage II–III HER2-positive breast cancer. This approach represents a novel strategy that reduces treatment burden, minimises toxicity, and preserves quality of life in a subset of patients with early HER2-positive breast cancer.

Cancer-related NHS hospital care costs by stage at diagnosis differed between cancer types; this heterogeneous pattern could inform detailed and nuanced economic evaluations of early detection initiatives.

Adding ipilimumab and nivolumab to percutaneous hepatic perfusion significantly improved progression-free survival, but with a higher rate of adverse events. The combination therapy offers a promising new treatment paradigm for patients with metastatic uveal melanoma. These results would ideally be validated in larger, multicentre randomised trials; however, conducting such studies is challenging due to the low incidence of uveal melanoma.

This nomogram predicts ADT-free survival after MDT in oligorecurrent prostate cancer. While individual-level discrimination was modest, risk-group stratification showed meaningful separation, supporting its potential use in treatment selection.

Concurrent chemoradiotherapy followed by immune checkpoint inhibitor (ICI) consolidation is now the standard of care for unresectable stage III non-small-cell lung cancer (NSCLC) and is increasingly applied to other thoracic malignancies. Although survival outcomes have improved, concerns about cardiac toxicity have emerged, as both chemoradiotherapy and ICIs are independently cardiotoxic and their combined effects remain unclear. This scoping review first examines chemoradiotherapy-associated and ICI-associated cardiac toxicity separately, and then evaluates their convergence in combined chemoradiotherapy and ICI therapy.

Currently, no consensus exists regarding the definition of oligometastatic pancreatic ductal adenocarcinoma, its necessary diagnostic measures, and potential treatment approaches. To address these knowledge gaps, the OligoPanc project brought together an interdisciplinary group of experts to establish consensus using a modified Delphi process and clinical vignettes. Participants agreed that the number of metastatic lesions and the number of affected organs are key elements in defining oligometastatic pancreatic ductal adenocarcinoma.

Radiotherapy and systemic therapies have revolutionised cancer treatments and improved survival, with generally acceptable toxicity. Modern radiotherapy techniques offer precision in targeting tumours, while minimising harm to the surrounding tissues. Novel systemic therapies represent opportunities for combining innovative treatments with radiotherapy. New agents are increasingly more tumour-specific than chemotherapy, and new rational combinations with radiotherapy are emerging, allowing for a more personalised approach.

This international Delphi study, led by the European Society of Radiation Oncology as part of their Value-Based Radiation Oncology programme, brought together key experts from the radiation oncology community to build consensus on both the level of evidence and the endpoints that are essential to support clinical implementation or policy decisions (eg, reimbursement) for different types of radiotherapy innovations. Although randomised trial evidence remained a high priority across most innovation types, other evidence, such as high-quality prospective observational studies or alternative designs such as pragmatic trials, was found to be a suitable alternative in specific scenarios.

Presenting on behalf of a large international team, Martin Heidinger (DBM Hebelstrasse, Basel, Switzerland), showed results from a preplanned analysis of the TAXIS/OPBC-03 phase 3 trial. Axillary lymph node dissection (ALND) is the standard of care for patients with node-positive breast cancer after neoadjuvant chemotherapy or upfront surgery. The use of tailored axillary surgery (TAS) to reduce axillary tumour burden to a degree where radiotherapy might be able to control the remaining extent of disease could reduce morbidity.

On Feb 28, 2026, Indian Prime Minister Narendra Modi unveiled a national campaign to promote human papillomavirus (HPV) vaccination to prevent cervical cancer. During the 90-day drive, 11·5 million girls aged 14 years will be administered the vaccine for free at government-run health facilities across the country. “This is the largest free HPV vaccination campaign in history”, said WHO Director-General Tedros Adhanom Ghebreyesus (WHO, Geneva, Switzerland). After the current campaign ends, the Indian health ministry will integrate the HPV vaccine into the Universal Immunisation Programme (UIP) and make it available at government health facilities during routine immunisation days, Health Minister Jagat Prakash Nadda (New Delhi, India) announced while addressing a virtual press conference, along with Ghebreyesus, on March 5.

These findings show that AI applied to routine histopathology can serve as a practical and scalable tool for guiding chemotherapy decisions in hormone receptor-positive, HER2-negative, early breast cancer. This approach has the potential to reduce unnecessary chemotherapy and broaden access to precision oncology, particularly in resource-limited settings where genomic testing remains unavailable or unaffordable.

Benmelstobart plus anlotinib showed longer progression-free survival than pembrolizumab plus placebo and no unexpected safety signals were reported, suggesting benmelstobart plus anlotinib as a potential first-line option in driver gene-negative, PD-L1-positive, advanced NSCLC. Longer term follow-up is needed to establish effects on overall survival.

We present new risk nomograms by PROMISE along with a simple table to prognosticate 3-year, 5-year, and 7-year overall survival in prostate cancer. PROMISE and PPP3 assessments are freely available online for global implementation.

The Government of Canada and five partner organisations have committed more than CA$41 million to fund 19 cancer prevention research teams over 5 years. The announcement was made on Feb 26, 2026, at Princess Margaret Cancer Centre in Toronto by Marjorie Michel, Canada's Minister of Health. It is the single largest investment in cancer prevention research ever led by the Canadian Institutes of Health Research (CIHR).

On Feb 27, 2026, lawmakers in the UK voted to sign into law the Rare Cancers Bill. The bill was proposed by Scott Arthur, a Member of Parliament for the ruling Labour Party based in Scotland, and a medical doctor. The bill will help accelerate research innovation to improve treatments and survival for rare cancers, including brain tumours and pancreatic cancer. The new law will take effect just as the UK has launched two major plans—The National Cancer Plan for England, and The England Rare Diseases Action Plan 2026.

On Feb 26, 2026, WHO announced that South Sudan's leadership had signalled renewed political attention to cancer control after Vice President, Josephine Lagu Yanga, met with WHO officials in Juba to discuss strengthening prevention, screening, treatment, and palliative care. The talks came as the country begins to mobilise a more coordinated response to cancer.

Since 1992, the surgical treatment for melanoma has substantially changed,1 and in clinically negative nodal basin, elective lymph node dissection has been overtaken by the sentinel node biopsy (SNB) followed by complete lymph node dissection in the case of positivity to SNB at the histopathological report. Many different studies have examined these methods, looking at specific subclinical features such as micro-metastases or macro-metastases,2 SNB tumour burden,3 number of SNBs, number of positive non-sentinel lymph nodes, and number of excised non-sentinel lymph nodes.

This meta-analysis showed that people with melanoma who underwent SNB had a significantly reduced risk of death from melanoma and recurrence compared with those who did not. These findings are consistent with the only published randomised controlled trial and were robust on sensitivity analyses, indicating that SNB confers true survival and recurrence benefits.

Historically, perioperative cisplatin based neoadjuvant therapy has remained the gold standard for muscle-invasive bladder cancer. In the past 5 years, several practice changing trials have enabled the incorporation of immune checkpoint inhibitors in the perioperative setting for muscle-invasive bladder cancer. The phase 3 NIAGARA study led to the approval of durvalumab in combination with gemcitabine or cisplatin followed by adjuvant immune checkpoint inhibitor monotherapy.1 The CheckMate-274 and AMBASSADOR trials showed improved outcomes in patients treated with adjuvant immune checkpoint inhibitors.

Perioperative sacituzumab govitecan plus pembrolizumab revealed a promising clinical complete response rate, without the occurrence of grade 4 or higher adverse events, allowing a bladder preservation with sustained remission in approximately 40% of patients.

On Feb 15 (commemorating the World Childhood Cancer Day), Jordan announced three linked initiatives: a National Cancer Control Strategy 2026–2030, six national paediatric cancer clinical guidelines, and its entry into the Global Platform for Access to Childhood Cancer Medicines. The event was jointly organised by the Ministry of Health and WHO under the patronage of Princess Ghida Talal of the King Hussein Cancer Foundation and King Hussein Cancer Center (KHCC; Amman, Jordan). The event also included participation of civil society organisations supporting patients with cancer (among panellists), to foster meaningful engagement of patients in line with WHO guidance.

February 15 is International Childhood Cancer Day, with 2026 marking the cumulation of a 3-year campaign, “Equal Access to Care for All Children with Cancer.” 400 000 children are diagnosed with cancer annually and, by disability-adjusted life-years, childhood cancer ranks as the sixth leading cause of cancer burden and ninth highest in childhood disease burden. Childhood cancer is now the leading cause of non-communicable disease-related death among children and adolescents in low-income and middle-income countries (LMICS) as well as in high-income countries.

The editorial team at The Lancet Haematology would like to extend our thanks to the many experts who offered their time and expertise to help us make decisions on and improve papers in 2025. In this issue we publish a list of clinical and statistical peer reviewers—we hope that some small recognition of an important academic task can be given to those who give their time, knowledge, and expertise. The Journal's success was partially reflected in our 2024 Impact Factor of 17·7 and Scopus CiteScore of 23·8.

In their study in The Lancet Haematology, Mahé and colleagues report a post-hoc analysis of the API-CAT randomised, double-blind, non-inferiority trial, identifying predictors of clinically relevant bleeding during 12 months of extended apixaban therapy in patients with active cancer who had completed at least 6 months of anticoagulation for venous thromboembolism (VTE).1 Among 1766 participants, clinically relevant bleeding occurred in 238 patients (cumulative incidence 13·9%), including 61 major bleeding events (3·6%).

We read with interest the post-hoc analysis of the pivotal API-CAT trial by Isabelle Mahé and colleagues, published in The Lancet Haematology,1 that found anaemia and/or thrombocytopenia, age 75 years or older, pulmonary embolism as the index event, and male sex to be associated with an increased risk of clinically relevant bleeding during extended anticoagulation for cancer-associated venous thromboembolism (VTE). The authors concluded that these results were homogenous across cancer sites. However, upon closer inspection of the subgroup analyses, we noted potentially substantial heterogeneity among the identified predictors of clinically relevant bleeding according to cancer site.

We thank Faizan Khan and Nick van Es, and Zhang Cheng and Yiqi Jin for their Correspondence regarding our post-hoc analysis of the API-CAT trial1,2 in which we identified four non-cancer related, non-modifiable predictors of clinically relevant bleeding during 12 months of extended apixaban therapy in patients with cancer-associated venous thromboembolism (VTE).

Iron deficiency during pregnancy is associated with an increased risk of postpartum haemorrhage, preterm birth, pre-eclampsia, fetal growth restriction, maternal mortality, and neurodevelopmental abnormalities in infants and during early childhood.1,2 The American College of Obstetricians and Gynaecologists recommends prophylactic oral iron (30 mg per day) rather than treatment of non-anaemic iron deficiency due to insufficient high-quality evidence concerning the effect of treatment on fetomaternal outcomes.

Kabbara F, Charbel N, Klim J, et al. Thalassaemia clinical trials in war-stricken Lebanon: a story of struggle and resilience. Lancet Haematol 2026; 13: e6–7—In this In Focus piece, Ghida Ismail and Farah Ismail should have been included in the author list. Ghida Ismail's affiliation of EpiMaCT - Epidemiology of chronic diseases in tropical zone, Institute of Epidemiology and Tropical Neurology, Omega Health, University of Limoges, CHU Limoges, INSERM U1094, IRD U270, Limoges, France, should have been included and both Ghida Ismail and Farah Ismail should have been added to the affiliation of Chronic Care Center, Hazmieh, Lebanon.

My Blood, Your Blood, a new children's book by author and producer Laura Henry-Allain MBE and illustrated by Zenovia Grant, is full of heroes. Based on the real-life experience of 13-year-old Angel Salami, it follows her, aged 4 years, bravely enduring a sickle cell crisis and receiving a blood transfusion in hospital. Back playing with her friends at the end of the story, she pays tribute to the other anonymous heroes in the book: “Every day I think about the person whose blood was given to me.”

Allogeneic haematopoietic cell transplantation (HCT) remains a potentially curative option for patients with high-risk haematological malignancies, albeit at the cost of substantial morbidity and mortality. Advances in transplantation practices and supportive care have expanded eligibility to older patients and to those with significant comorbidities. In this evolving landscape, frailty assessment has become a crucial component of pre-transplantation evaluation, as it is consistently associated with increased transplantation-related complications, prolonged hospitalisation, and inferior survival.

Var-cel induced deep remissions with low incidence of severe cytokine release syndrome and any-grade immune effector cell-associated neurotoxicity syndrome, supporting fractionated dose escalation as a strategy that preserves activity, limits acute toxic effects, and supports a hospital-based approach that could expand access to CAR T-cell therapy.

Adverse events during induction and reinduction were consistent with those reported in previous infant acute lymphoblastic leukaemia studies. Infections remain a substantial cause of morbidity and mortality in this immunocompromised patient population and extended beyond the induction and reinduction chemotherapy phases.

High-dose cytarabine and mitoxantrone plus venetoclax appeared to be safe, showed promising activity, and could be a new therapeutical approach for medically fit patients with relapsed or refractory acute myeloid leukaemia, especially as a bridge to allogeneic HCT.

The results indicate that quizartinib plus standard chemotherapy prolongs overall survival without adversely affecting patient-reported outcomes and health-related quality of life, with no substantial differences between groups. Future research in real-world settings is warranted to assess the generalisability of these patient-reported outcome results.

The distinction between myelodysplastic syndromes and acute myeloid leukaemia remains a subject of debate, with direct implications for clinical decisions, trial eligibility, and allogeneic hematopoietic cell transplantation allocation. Although the historical 20% blast threshold in bone marrow is commonly used to separate myelodysplastic syndromes from acute myeloid leukaemia, emerging evidence shows that morphological, cytogenetic, and molecular features provide a more accurate framework for diagnosis and risk stratification.

A 47-year-old man was admitted to Ruijin Hospital (Shanghai, China) in July, 2025, with widespread, tender, and violaceous cutaneous nodules on his trunk and extremities. PET–CT revealed hypermetabolic activity in the skin lesions, which involved cervical and inguinal lymph nodes (maximum standardised uptake value of 3·6–7·1). Laboratory studies revealed a white blood cell count of 11 × 109 cells per L. A skin biopsy showed a diffuse dermal infiltrate of monomorphic blastoid cells. Immunohistochemical analysis revealed that the neoplastic cells expressed CD123, TCF4, TCL1, CD4, CD56, HLA-DR, and aberrant cytoplasmic CD3 (figure A), with partial expression of CD2 and CD7.

In this Special Report, Cloos and colleagues present the 2025 European LeukemiaNet measurable residual disease (MRD) consensus recommendation for acute myeloid leukemia (AML), providing a unified framework for standardizing and clinically applying MRD assessment in AML. These guidelines outline preferred assay selection, analysis strategies, and key parameters including timing, tissue type, and cutoffs across molecular subtypes, and define MRD levels with corresponding clinical recommendations to enhance patient care.

Calcineurin inhibitors plus methotrexate are routinely used in patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation to prevent graft-versus-host disease (GVHD). Meyer and colleagues report the results of a prospective randomized trial comparing Orca-T, a deconstructed and reconstructed allogeneic T-cell–mobilized peripheral blood graft, to a conventional unmanipulated peripheral blood graft using tacrolimus plus methotrexate as GVHD prophylaxis in the context of matched sibling transplantation. Orca-T showed superior chronic GVHD–free survival compared to the control arm (78.0% vs 38.4%, P< .001) and lower nonrelapse mortality (3.4% vs 13.2%, P = .03).

VEXAS (vacuoles, E1 enzyme, X-linked, autoinflammatory, somatic) syndrome is an inflammatory disorder characterized by a cytoplasm-restricted defect in ubiquitylation due to somatic mutations in UBA1. Rodrigues and colleagues show that mature red cells from patients with VEXAS syndrome do not exhibit ubiquitylation defects, and patient-derived erythroblasts lack UBA1 mutations. Base editing of UBA1 variants in CD34⁺ cells inhibits in vitro erythroid differentiation, providing a mechanism for the anemia seen in many patients with VEXAS syndrome and implying that the severity of anemia in these patients is determined by the ratio of wild type vs mutated UBA1 in the erythroid compartment.

Chimeric antigen receptor (CAR) T-cell therapy targeting B-cell maturation antigen has demonstrated high efficacy in the treatment of relapsed/refractory multiple myeloma, but emerging data raise concerns for secondary T-cell lymphoma. Through meticulous and sequential phenotypic, genomic, and transcriptomic analyses, Hosoya and colleagues report a case of premalignant CAR T cells arising from preexisting clonal hematopoiesis, coexpressing the gut-homing integrin receptor α4β7 and giving rise to lymphoma of the gastrointestinal tract in the treated patient.

Current classification of anaplastic large cell lymphoma (ALCL) does not address molecular heterogeneity. Based on gene signatures derived from RNA sequencing analysis of 393 patients, Feldman and colleagues provide a framework to harmonize many different ALCL clinicopathologic entities into 2 major subsets, dubbed type I and type II ALCL, which could be predicted with 91% accuracy based on the presence (type I) or absence (type II) of phosphorylated STAT3^Y705 expression (P< .0001). Future studies should determine the clinical utility of this molecular classification.

Myeloproliferative neoplasms (MPNs) are inflammatory diseases that result from interactions of mutated hematopoietic stem and progenitor cells (HSPCs) with the bone marrow niche. Lu and coauthors developed a novel simplified triculture system of HSPCs with endothelial cells and mesenchymal stromal cells that recreates the bone marrow microenvironment. By transcriptional profiling, the authors demonstrate that the proinflammatory response is a result of the interactions of these cells, confirming the microenvironmental dependency, cross talk, and inflammatory remodeling in MPNs.

Aberrant expression of oncofetal chondroitin sulfate (ofCS) has been reported in multiple cancers and has been proposed as a tumor agnostic target. Mujollari and colleagues report aberrant expression ofCS on malignant blasts in acute myeloid leukemia (AML) and myelodysplastic syndrome and demonstrate its drugability using an antibody drug conjugate that binds and kills AML cells while sparing normal bone marrow cells in xenograft models. The authors’ study sets up the basis for a potential novel therapeutic strategy for AML.

Berzosertib (200 mg/m2 iv weekly) was safe when combined with chemoradiation but did not improve complete response rate in LA‐HNSCC.

The MSKD is feasible in patients with PDAC and, although not powered for definitive outcomes, shows trends in improved PFS and OS when combined with gemcitabine, nab‐paclitaxel, and cisplatin, without added toxicity or detriment to QOL. Larger studies are required to confirm these findings and establish the value of the MSKD in pancreatic cancer treatment.

The addition of trastuzumab to CRT for localized HER2+ EAC did not improve PROs.

Collectively, the current data support the GHS/QoL benefit of first‐line cemiplimab monotherapy versus chemotherapy overall and in multiple subpopulations of patients with programmed cell death‐ligand 1 expression ≥50% advanced non‐small cell lung cancer.

Breast cancer chemotherapy regimens used in the real‐world setting were examined. Chemotherapy modifications varied markedly by regimen and by characteristics of the regimen administered. Given that more than one in three women in this cohort did not receive chemotherapy as intended, these novel findings may be informative in treatment planning and for future research assessing real‐world treatment effectiveness.

Racial and ethnic differences were found in office‐based mental health care professional visits, related expenditures, and prescription medication use among cancer survivors with SPD, which calls for equitable interventions in mental health care.

The concurrent use of enzalutamide, apalutamide, or abiraterone with DOACs did not contribute to clinically meaningful changes in the risk of thrombosis or bleeding in individuals with prostate cancer.

A population-level cohort study of 264.4 million deaths across 20 countries found that females born since the 1930s had higher cancer mortality than males between the ages of 35 and 60 years, largely due to breast and gynecologic cancers. Although females live longer than males on average, these...

In a phase I trial (PYNNACLE) reported in The New England Journal of Medicine, Dumbrava et al described the toxicity and preliminary activity of rezatapopt in TP53 Y220C–mutated solid tumors. The agent is an investigational, first-in-class, oral, selective p53 reactivator that specifically binds to ...

In a Chinese phase II study (CAREMM-001) reported in the Journal of Clinical Oncology, Yan et al found that B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy was highly active in patients with newly diagnosed multiple myeloma who were ineligible for or did not proceed...

Significant differences were found in advanced-stage diagnoses of breast cancer in rural populations according to geographic location in the United States, which were further influenced by demographic factors of race and insurance status, according to findings from an analysis of the National...

Severe COVID-19 and influenza infections may prime the lungs for cancer and can accelerate the disease’s development—but vaccination heads off those harmful effects, according to new research published by Qian et al in Cell.

T-cell lymphomas are notoriously difficult to treat because immunotherapy, despite being one of the most effective therapies for treating cancer, can’t easily distinguish cancerous T cells from healthy ones. Now, scientists at The Wistar Institute have designed a two-vaccine approach that not only...

A structured exercise program in patients with cancer receiving chemotherapy led to a reduction in self-reported cognitive impairment vs those receiving chemotherapy who were not on an exercise plan, according to findings from a nationwide, randomized phase III trial published in JNCCN—Journal of...

In a study reported in the Journal of Clinical Oncology, investigators from the Hereditary Breast Cancer Clinical Study Group found that women with ovarian cancer with pathogenic/likely pathogenic BRCA1/2 variants had low risk for subsequent breast cancer.

In a Dutch single-center phase II trial (CHOPIN) reported in The Lancet Oncology, van den Hoek et al found that the addition of nivolumab and ipilimumab to percutaneous hepatic perfusion improved progression-free survival in patients with metastatic uveal melanoma.

The U.S. Food and Drug Administration (FDA) has released a new draft guidance to streamline the development of biosimilars. This, and prior versions of the draft guidance for industry, reflect actions being taken by the agency to lower the cost of drugs. 

Integration of artificial intelligence (AI) into screening workflows increased the detection of breast cancer by 10.4% in the United Kingdom, according to the results of the GEMINI study published in Nature Cancer. Additionally, use of AI in different workflows led to reductions in workload by up...

The Pezcoller Foundation–American Association for Cancer Research (AACR) International Award for Extraordinary Achievement in Cancer Research will be presented to Douglas R. Lowy, MD, and John T. Schiller, PhD, during the AACR Annual Meeting 2026, to be held April 17 to 22 at the San Diego...

A new study has found that patients with prostate cancer and low testosterone levels may have a higher risk of their cancer progressing to a more aggressive form while under active surveillance.

In an Italian single-center phase II trial (SURE-02) reported in The Lancet Oncology, Necchi et al found that neoadjuvant sacituzumab govitecan-hziy plus perioperative pembrolizumab produced a “promising” clinical complete response rate in patients with muscle-invasive bladder cancer who were...

In a study of adults with advanced prostate cancer taking androgen-receptor pathway inhibitors (ARPIs) and different types of anticoagulants, investigators found no evidence of an increase in patients’ bleeding or clotting risks, despite previous lab results that raised alarms. These findings were...

The 2025 San Antonio Breast Cancer Symposium (SABCS 2025) featured some exciting presentations.

In a European phase II/III trial (AXINET) reported in the Journal of Clinical Oncology, Garcia-Carbonero et al found that the addition of axitinib to long-acting octreotide appeared to show activity in patients with advanced extrapancreatic neuroendocrine tumors (epNETs).

A novel KRAS G12D inhibitor produced disease control in almost 80% of patients with heavily pretreated advanced or metastatic KRAS G12D–mutated pancreatic cancer in an early-phase study reported at the 2026 ASCO Gastrointestinal (GI) Cancers Symposium.¹

Building upon the foundation of liquid biopsy utility for the early detection of cancer, analysis of genome-wide cell-free DNA fragmentation with machine learning classification and modeling can also extend to the identification of liver cirrhosis and other chronic diseases, according to findings...

In a Chinese phase II trial (CHANCE2005/CARES-005) reported in the Journal of Clinical Oncology, Zhu et al found that the addition of camrelizumab and rivoceranib to transarterial chemoembolization (TACE) improved progression-free survival in patients with unresectable hepatocellular carcinoma.

Researchers have identified that the reporting of venous and arterial thrombotic events in cancer clinical trials is inconsistent and potentially inaccurate, according to a comments article published in the Journal of Clinical Oncology.¹

Quadrivalent human papillomavirus (HPV) vaccination led to a significantly reduced risk of invasive cervical cancer that was sustained through long-term follow-up, according to the results of a Swedish nationwide, register-based cohort study published in The BMJ. 

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.

Author Correction: Innovative approaches for lung cancer screening and interception

The development of immune checkpoint inhibitors and novel targeted therapies and the incorporation of these agents into first-line therapy for biomarker-selected patients with metastatic gastric cancer has improved outcomes. Nonetheless, many challenges remain, including both primary and acquired resistance as well as a lack of relevant biomarkers in certain subgroups. In this Review, the authors describe the current approach to first-line therapy for patients with metastatic gastric cancer as well as emerging approaches that might improve the standard of care in the coming years.

Glucagon-like peptide 1 receptor agonists (GLP1RAs) are widely used by individuals with type 2 diabetes mellitus (T2DM) and/or obesity. Both of these conditions are also associated with an increased risk of certain cancers, and this risk might be ameliorated following intentional weight loss, which can consistently be achieved with GLP1RAs. Conversely, several reports have suggested an increased risk of certain cancers, such as medullary or non-medullary thyroid cancer and pancreatic cancer among those receiving GLP1RAs. In this Review, the authors evaluate these competing risks and the underlying evidence as well as highlighting areas in which evidence is limited and more research will be needed in order to definitively understand the implications of GLP1RAs for cancer risk.

Although oncology advances stem from clinical research, <5% of global cancer trials actively recruit patients in Latin America. Herein, I discuss why expanding inclusive trial designs and fostering multisector partnerships are essential to reduce disparities and improve the role of Latin America in global oncology research. I present examples such as the recent regulatory reforms in Brazil that aim to accelerate study approvals, as well as collaborative initiatives between local and international research groups to further strengthen clinical trial capacity.

Lisocabtagene maraleucel has high efficacy in R/R MZL

Cholangiocarcinomas, comprising intrahepatic, extrahepatic and perihilar subtypes as well as gallbladder cancer, are a heterogeneous group of malignancies that necessitates a personalized approach to both surgery and systemic therapy. In this Review, the authors describe progress in the development of personalized perioperative therapy strategies as well as the most promising future research directions in this diverse and often difficult-to-treat group of cancers.

Enfortumab vedotin plus pembrolizumab effective in patients with resectable bladder cancer

Despite substantial interest in exploiting ferroptosis — an iron-mediated, lipid peroxidation-driven form of cell death — for cancer therapy, progress towards clinical translation has been limited. This comprehensive Review describes the major barriers that have restricted ferroptosis-based therapeutic development as well as emerging opportunities presented by new ferroptosis-inducing agents, biomarker-guided patient selection and rational combination treatments.

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In this episode of Denatured, you’ll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We speak about how the FDA’s latest decision to have one, rather than two pivotal studies, for new drug applications raises the bar for data collection and risk-based management.

Dyne Therapeutics is plotting an approval application for z-rostudirsen in the back half of 2026—a push that will only be bolstered by the departure of controversial CBER chief Vinay Prasad, according to analysts at Stifel.

Single-trial approvals are raising the bar on trial design and execution. The new paradigm is pushing sponsors to plan earlier, step up their data and risk‑based quality management and use modeling and AI to generate one compelling, regulator‑ready evidence package.

Zealand Pharma’s shares fell 32% in early morning trading Friday after its Roche-partnered asset petrelintide failed to meet investor expectations in a mid-stage clinical trial.

In this episode of Denatured, you’ll be listening to Indu Navar, CEO and founder of EverythingALS and Dr. Olga Uspenskaya, chief medical officer at VectorY Therapeutics. We’ll be speaking about patient-pharma collaborations accelerating trials and hope, advances in ALS biology understanding and biomarker-driven endpoints.

A trial of a MacroGenics’ drug temporarily paused enrollment after several safety events, including a fatality. The deceased patient had developed a severe case of neutropenia and concurrent septic shock.

Following Monday’s clinical defeat by Eli Lilly, Novo Nordisk cut the 2027 list prices for its three GLP-1 medicines by as much as 50%, while boasting Phase 2 data for its invesigational triple-G agonist.

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.

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.

In this episode of Denatured, you’ll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We speak about how the FDA’s latest decision to have one, rather than two pivotal studies, for new drug applications raises the bar for data collection and risk-based management.

Vertex Pharmaceuticals has a rolling biologics license application with the FDA for povetacicept in IgA nephropathy. With new data from RAINIER, the biotech expects to complete its submission by the end of March.

Single-trial approvals are raising the bar on trial design and execution. The new paradigm is pushing sponsors to plan earlier, step up their data and risk‑based quality management and use modeling and AI to generate one compelling, regulator‑ready evidence package.

Roche’s shares tumbled nearly 5% on news that a key pillar in the five-pronged clinical plan for the breast cancer asset giredestrant was unsuccessful.

Azetukalner, a Kv7 potassium channel opener, reduced the frequency of focal onset seizures by a placebo-adjusted rate of 42.7%. Xenon Pharmaceuticals believes this is the highest such efficacy “observed in a pivotal epilepsy study,” CEO Ian Mortimer said Monday.

Ipsen will withdraw Tazverik’s follicular lymphoma and epithelioid sarcoma indications as emerging data point to an elevated safety risk in patients undergoing treatment.

The FDA last October paused Intellia Therapeutics’ late-stage CRISPR studies after detecting life-threatening enzyme elevations in one patient, who died a few days later.

Days after FDA Commissioner Marty Makary appeared to malign uniQure’s AMT-130 in an interview with CNBC, the agency confirmed to the biotech that a sham surgery–controlled study is needed before submitting the gene therapy for approval.

Aardvark Therapeutics is down 54% since Friday after the biotech said it detected “reversible cardiac observations” in a healthy volunteer study of its drug to treat extreme hunger in patients with the rare genetic disease.

A combination of Merck’s Keytruda and Pfizer’s Padcev could offer a chemotherapy-free treatment alternative for patients with muscle-invasive bladder cancer, even those eligible for cisplatin treatment.

Data from BridgeBio Pharma’s Phase 3 FORTIFY study show that BBP-418 significantly increases levels of a key disease biomarker that helps stabilize muscles in patients with limb-girdle muscular dystrophy.

Data presented at the 2026 Muscular Dystrophy Association meeting could have readthroughs to companies developing therapies for spinal muscular atrophy, Duchenne muscular dystrophy and Becker muscular dystrophy.

In this episode of Denatured, you’ll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We speak about how the FDA’s latest decision to have one, rather than two pivotal studies, for new drug applications raises the bar for data collection and risk-based management.

Dyne Therapeutics is plotting an approval application for z-rostudirsen in the back half of 2026—a push that will only be bolstered by the departure of controversial CBER chief Vinay Prasad, according to analysts at Stifel.

Vertex Pharmaceuticals has a rolling biologics license application with the FDA for povetacicept in IgA nephropathy. With new data from RAINIER, the biotech expects to complete its submission by the end of March.

Single-trial approvals are raising the bar on trial design and execution. The new paradigm is pushing sponsors to plan earlier, step up their data and risk‑based quality management and use modeling and AI to generate one compelling, regulator‑ready evidence package.

AbbVie’s foray into the obesity space is successful so far, analysts agree, as amylin analog ABBV-295 elicited as much as 9.73% weight loss at 13 weeks in the multiple ascending dose portion of a Phase 1 trial.

Roche’s shares tumbled nearly 5% on news that a key pillar in the five-pronged clinical plan for the breast cancer asset giredestrant was unsuccessful.

Azetukalner, a Kv7 potassium channel opener, reduced the frequency of focal onset seizures by a placebo-adjusted rate of 42.7%. Xenon Pharmaceuticals believes this is the highest such efficacy “observed in a pivotal epilepsy study,” CEO Ian Mortimer said Monday.

Ipsen will withdraw Tazverik’s follicular lymphoma and epithelioid sarcoma indications as emerging data point to an elevated safety risk in patients undergoing treatment.

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).

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.

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