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Sometimes, as patients near the end of life, eliciting and fulfilling a simple wish can lead to acceptance and a peaceful death — a lesson absorbed by a physician during a week of ice cream.

In untreated, advanced triple-negative breast cancer, sacituzumab govitecan led to significantly longer progression-free survival than chemotherapy (9.7 months vs. 6.9 months).

This review updates the pathophysiology and disease course of acromegaly, focusing on the general clinician’s key role in early diagnosis and management.

A 79-year-old man was admitted to a hospital in Guangzhou, China, with progressive dyspnea and edema. Echocardiography and computed tomography revealed a mass in the right atrium. A diagnosis was made.

When a patient’s family struggles to grasp what enrolling him in hospice will mean, a physician recognizes the limits of the standard script about hospice care.

In advanced HER2-mutant NSCLC, sevabertinib showed antitumor activity, with responses in 64 to 71% of patients not previously treated with HER-directed antibody–drug conjugates and in 38% of previously treated patients.

In intermediate-risk breast cancer, postmastectomy chest-wall irradiation did not improve 10-year overall survival as compared with no chest-wall irradiation.

In the management of breast cancer, treatment approaches are locoregional (i.e., surgery and radiotherapy) or systemic (i.e., chemotherapy, targeted therapy, endocrine therapy, and immunotherapy). The two approaches and their components relate to and complement each other in a delicate balance, with an improvement in efficacy on one side allowing for...

In advanced non–small-cell lung cancer with EGFR mutations, amivantamab–lazertinib led to longer overall survival than osimertinib but was associated with an increased risk of adverse events of grade 3 or higher.

At 23 years of follow-up, population-based PSA screening of asymptomatic men led to a sustained reduction in prostate cancer mortality, although overdiagnosis remains a concern.

A 56-year-old man was admitted to the hospital because of left lower abdominal pain and anemia. He had a 1-year history of recurrent diarrhea and an enterocolonic fistula. A diagnosis was made.

In this episode of NOS, Lisa Rosenbaum and her guests consider the ideals and realities of primary care — and the expectations and misunderstandings that are contributing to its current crisis.

Approaches to early detection of cancer often seem contentious, but the big-picture view is actually one of remarkable consensus. All major guideline groups recommend the Papanicolaou smear, mammography, colonoscopy, and — in older adults with a substantial history of smoking — lung imaging; none recommend CA-125 for early detection of...

Somatic mutations in EGFR (epidermal growth factor receptor) account for approximately one third of lung cancer cases worldwide.1 A point mutation in exon 21 (L858R) or a short deletion in exon 19 are the most common EGFR variants. Tyrosine kinase inhibitors (TKIs) are the...

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

An 82-year-old woman with a history of congestive heart failure was admitted to this hospital for volume overload. Ascites, pleural effusions, and hypoalbuminemia were present. A diagnosis was made.

Additional efforts are needed to improve quality of life and mitigate suffering in people with sickle cell disease. The field of palliative care is well positioned to help address this need.

A study published in 1995 provided evidence that hydroxyurea reduces vaso-occlusive crises in people with sickle cell anemia. But most patients in sub-Saharan Africa still don’t have access to it.

In muscle-invasive bladder cancer, ctDNA-guided atezolizumab led to longer disease-free survival (9.9 vs. 4.8 months), as well as to longer overall survival (32.8 vs. 21.1 months), than placebo among ctDNA-positive patients.

In HER2-expressing urothelial cancer, disitamab vedotin plus toripalimab doubled the median progression-free survival, increased the median overall survival, and reduced adverse events as compared with chemotherapy.

A side event held by the Bloomberg New Economy International Cancer Coalition and American Society of Clinical Oncology at the 2025 UN General Assembly in New York, New York, USA, saw the launch of the Global Cancer Financing Platform, marking a pivotal step in reshaping how the world funds cancer care. This gathering brought together international stakeholders from across governments, industry, philanthropy, and civil societies to explore innovative financing models for cancer care. One highlight was the potential for diaspora remittances.

In The Lancet Oncology, Daniella Black and colleagues1 report whole-genome sequencing (WGS) data of 2445 breast cancer tumours from a UK cohort (100 000 Genomes Project [100kGP]). As well as linking these data to clinical and mortality data, the authors externally validated their results in a Swedish cohort (SCAN-B) of 502 cases. By integrating driver mutations, mutational signatures, and structural variation (SV) burden, the authors show that, alongside a handful of drivers known from other tumour types, a single WGS assay could identify potentially actionable alterations in 656 (26·8%) of all 2445 breast cancer cases in the 100kGP cohort.

Concurrent chemoradiotherapy followed by consolidation with durvalumab is the standard of care for patients with locally advanced non-small-cell lung cancer (NSCLC) who are medically or surgically inoperable, have a good performance status, and do not have actionable EGFR mutations.1 In the PACIFIC trial, consolidation treatment with durvalumab for up to 12 months after platinum-based chemoradiotherapy showed a 5-year progression-free survival rate of 33·1% (95% CI 28·0–38·2) and 5-year overall survival rate of 42·9% (38·2–47·4).

In addition to next generation small molecule tyrosine-kinase inhibitors,1,2 large molecular weight antibody–drug conjugates (ADCs) have shown CNS-specific activity, penetrating a blood–brain barrier that is disrupted by local therapies, the presence of brain metastases, or both.3 The adoption of these CNS-penetrant systemic therapies to treat patients with active brain metastases is increasingly accepted in routine practice, despite little data from randomised trials.

Androgen receptor pathway inhibitors (ARPIs) in combination with androgen deprivation therapy (ADT) represent the foundation of treatment for both metastatic castration-sensitive prostate cancer (mCSPC) and metastatic castration-resistant prostate cancer (mCRPC).1 In selected patients with mCSPC, the addition of six cycles of docetaxel further enhances overall survival outcomes.2 However, therapeutic resistance remains common and prostate cancer remains a substantial cause of cancer-related mortality.

In August, 2025, the US Food and Drug Administration (FDA) published a draft guidance on the assessment of overall survival in randomised cancer drug trials.1 In essence, the guidance states that overall survival and quality of life are the only clinical endpoints to confirm the benefit of any cancer therapies—ultimately, patients want longer and better lives as a trade-off for the toxic effects of treatment. However, in recent years the FDA has deprioritised the need to show an overall survival improvement from new cancer drugs, with several new cancer drugs receiving full approval on the basis of improvements in putative surrogate endpoints alone, often in the face of negative overall survival results.

In The Lancet Oncology, Louise Emmett and colleagues1 present an elegant prespecified substudy from the ENZA-p trial that shows that baseline prostate-specific membrane antigen (PSMA)-PET total tumour volume (PSMA-TTV) is not only prognostic for overall survival, but also predictive of benefit from adding [177Lu]Lu-PSMA-617 to enzalutamide as a first-line treatment in patients with high-risk, metastatic castration-resistant prostate cancer. However, whole-body standardised uptake value (SUV) mean did not show predictive value in this combination setting.

We congratulate Nicole Concin and colleagues with the effort put into the updated ESGO–ESTRO–ESP guidelines.1 Although we support the integration of oestrogen receptor status in the guideline, we wonder why progesterone receptor expression is not included. In our opinion, oestrogen receptor and progesterone receptor have additional prognostic and predictive value in endometrial cancer, and these receptors are cheap and well established biomarkers available worldwide for breast and endometrial cancer diagnosis.

We thank Vrede and colleagues for their interest in the ESGO–ESTRO–ESP guideline update1 and their comments regarding progesterone receptor immunohistochemistry.

I read with interest, the Article by Yichen Zhang and colleagues,1 which presents an important retrospective evaluation of the evidential standards underpinning cancer drug approvals in China between 2017 and 2021. Although the study admirably highlights methodological concerns surrounding trial design and bias, I wish to raise two additional critical methodological shortcomings that warrant further scrutiny.

Aggarwal A, Simcock R, Price P, et al. NHS cancer services and systems—ten pressure points a UK cancer control plan needs to address. Lancet Oncol 2024; 25: e363–73—In this Policy Review, the second sentence in paragraph 4 of the Pressure point 6 section should have said “six times” instead of “600 times”. This correction has been made to the online version as of Oct 27, 2025.

Dawson LA, Ringash J, Fairchild A, et al. Palliative radiotherapy versus best supportive care in patients with painful hepatic cancer (CCTG HE1): a multicentre, open-label, randomised, controlled, phase 3 study. Lancet Oncol 2024; 25: 1337–46—In this Article, in the last paragraph of the Results section, the proportion of patients who reported any grade 2 or worse adverse event 1–3 months after randomisation should have been eight (24%) of 33 patients in the radiotherapy plus best supportive care group.

Turner MC, Godderis L, Guénel P, et al. Carcinogenicity of automotive gasoline and some oxygenated gasoline additives. Lancet Oncol 2025; 26: 548–49—In the Declaration of interests section, statements have been corrected for Jorunn Kirkeleit. These corrections have been made to the online version as of Oct 27, 2025.

Demand for cancer care services is rising as Ukraine enters its fourth year of full-scale war, which has severely disrupted access to oncology diagnostics and treatment amid shortages of trained personnel, medical supplies, and funding, says a WHO report.

Non-communicable diseases (NCDs) now account for seven of the world's ten leading causes of death and kill 18 million people each year before age 70 years. WHO recently launched a new investment case urging countries to scale up proven, cost-effective interventions. The analysis, Saving Lives, Spending Less, estimates that implementing WHO's “best buys” in 176 countries would cost about US$3 per person annually. By 2030, the package could save more than 12 million lives, prevent 28 million heart attacks and strokes, add 150 million healthy life-years, and generate around US$1 trillion in economic benefits.

The UK National Health Service (NHS) is to construct and rollout a pioneering new cloud computer system that will allow artificial intelligence (AI) tools to be tested on an unprecedented scale across the NHS by cutting waste, duplication, and time needed to complete clinical trials, with a central aim to boost screening, including early diagnosis of cancer.

A new US$50 million Technical Assistance Facility (TAF) for non-communicable diseases (NCDs) and women's cancers will begin by supporting the elimination of cervical cancer in Indonesia. The initiative was launched by the Women's Health and Economic Empowerment Network (WHEN) and the Elimination Partnership in the Indo-Pacific for Cervical Cancer (EPICC) on Sept 24, 2025, in New York, NY, USA, at the sidelines of the UN General Assembly. “Cervical cancer elimination is a ‘best buy’ in NCD control.

The new 2025 edition of the Atlas of Palliative Care in Africa reveals a continent where palliative care services remain underdeveloped and essential medicines are scarce, with poor integration into health systems. Moreover, insufficient training is constraining Africa's ability to address serious health-related suffering (SHS), which is affecting an estimated 17·6 million people per year, driven by a rapidly rising burden of non-communicable diseases (NCDs) and ageing populations.

On Oct 8, 2025, a new law was introduced in British Columbia, Canada, that, if passed, will take action against e-cigarette (vape)manufacturing companies that cause harm to the public through deceptive promotion of vaping products. It is reportedly the first law in Canada that intends to recover health-care costs from companies involved in misleading activities to sell vaping products.

Over the past decade, subcutaneous formulations of anticancer drugs—originally administered intravenously—have been increasingly developed and subsequently approved by the US Food and Drug Administration (FDA). This new route of administration benefits patients with increased convenience. In this essay, we describe and discuss the growing adoption of subcutaneous formulations and also consider the potential future economic effects, particularly in relation to immunotherapy.

In part due to its rare occurrence, cancer during pregnancy poses unique challenges that require careful consideration of both maternal and fetal health. For the best possible outcome for both mother and child, management during pregnancy should closely follow established guidelines.1 Oncological staging is necessary to identify optimal personalised treatment plans for each patient, and should be performed in the same manner as for patients who are not pregnant. However, selecting appropriate imaging methods, especially among those that use ionising radiation, requires a careful balance between maternal benefits and fetal risks.

We show that breast cancer genomes are rich in predictive and prognostic value. We propose a two-step model for effective clinical application. First, the identification of candidates for targeted therapies or clinical trials using highly individualised genomic markers. Second, for patients without such features, the implementation of enhanced prognostication using genomic features alongside existing clinical decision-making factors.

These findings suggest that pembrolizumab combined with platinum-based chemotherapy, without radiotherapy, might provide a feasible and promising alternative treatment strategy for patients with unresectable, locally advanced NSCLC with a PD-L1 TPS of 50% or higher.

Compared with single PD-L1 or PD-1 inhibition, dual immune checkpoint blockade with CTLA-4 and PD-L1 or PD-1 inhibitors was associated with improved overall survival in patients with advanced NSCLC and PD-L1 TPS less than 1% and in those with STK11 mutations, but not in the overall population. Prospective validation of these results in clinical trials is warranted.

HER3-DXd showed promising clinical activity in patients with advanced NSCLC and active brain metastases, and could represent a novel treatment option in this setting.

HER3-DXd showed promising clinical activity in patients with metastatic breast cancer and active brain metastases, and could offer a novel therapeutic option in this setting.

The combination of 177Lu-PSMA-I&T and 223Ra is safe and feasible in patients with metastatic castration-resistant prostate cancer and bone metastases. These findings warrant further evaluation of combined α-emitting and β-emitting approaches.

Dual inhibition of CDK4 and CDK6 and the androgen receptor pathway with abemaciclib plus abiraterone did not improve radiographic progression-free survival compared with abiraterone alone in the CYCLONE 2 study population with mCRPC. Safety of the combination was consistent with the previously reported safety of the individual drugs. Additional research is required to identify effective combination therapies for patients with mCRPC, especially in those presenting with adverse prognostic characteristics.

This interim analysis indicated that there is no benefit from imaging in the follow-up programme for individuals with high-risk cutaneous malignant melanoma. However, only a few participants have completed the follow-up time of 5 years, and the numerical difference between the study groups in distant metastasis-free survival motivates us to continue the study according to protocol.

Advances in cancer immunotherapy from immune checkpoint modulation to adoptive cell transfer of tumour-infiltrating lymphocytes (TILs) have greatly improved outcomes for patients with advanced cancers, particularly metastatic melanoma. The approval of TIL therapy in 2024 following two independent landmark clinical trials has established this approach as a viable treatment option, with response rates of up to 50% in treatment-resistant melanoma. Genetic engineering offers new opportunities to further improve TIL efficacy and durability, including viral vector-mediated overexpression of cytokines or chimeric receptors, and non-viral genome editing techniques such as CRISPR-Cas9 to delete inhibitory genes such as PD-1 and CISH.

Measurable residual disease (MRD) is a key predictor of relapse, the primary cause of treatment failure after allogeneic haematopoietic cell transplantation (allo-HCT) in acute myeloid leukaemia. This Policy Review, based on guidance from the European Society for Blood and Marrow Transplantation, provides practical recommendations for incorporating MRD assessment into clinical decision making during the transplantation process, the application of which remains challenging in acute myeloid leukaemia due to technical limitations and the limited availability of standardised, evidence-based approaches.

Artificial intelligence (AI) has the potential to enable more precise, efficient, and reproducible interpretation of medical imaging data to improve patient care in paediatric neuro-oncology. Paediatric brain tumours present distinct histopathological, molecular, and clinical challenges that require tailored AI solutions. Recent advances have led to paediatric-specific AI tools for tumour segmentation, treatment response evaluation, recurrence prediction, toxicity assessment, and integrative multimodal analysis.

The Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria provide an important framework for evaluating treatment efficacy and tumour progression in clinical studies of paediatric brain tumours. As artificial intelligence (AI) rapidly transforms clinical practice, integrating AI into the RAPNO framework presents a unique opportunity to enhance quantitative, data-driven approaches for response assessment. However, successful clinical implementation faces challenges, including variability in imaging protocols, scarce annotated datasets, and regulatory and ethical considerations.

A 62-year-old woman with Behçet's syndrome presented to the Department of Oral Medicine at Institut Universitaire du cancer Toulouse-Oncopole (Toulouse, France) in May, 2025, following an incidental discovery of a palatal lesion during a dental consultation. The lesion had been persistent for 2 months prior to presentation.

The effects of Medicare funding cuts and the longest ever shutdown of the US Federal Government have slowed momentum to a standstill in cancer prevention, screening, and treatment, warned the Association of American Cancer Institutes (AACI), which represents more than 100 academic and freestanding cancer centres in the USA and Canada.

Implementation of lung cancer screening is advancing globally, and most countries use categorical eligibility criteria resembling those from randomised low-dose CT screening trials. For example, the US Preventive Services Task Force (USPSTF) requires age 50–80 years, at least 20 pack-years smoked, and 15 years or less of cessation. However, beginning in 2013, studies suggested that defining eligibility using individual lung cancer risk prediction models would yield more lung cancer deaths prevented per population screened.

Participant selection using the PLCOm2012 risk prediction model with a 6-year risk of at least 1·58% cutoff is more efficient and effective in detecting lung cancer than the NELSON criteria and should therefore be implemented in lung cancer screening programmes.

The UK has had serial national cancer control plans (NCCPs) since 1997. Early progress was undeniable, but momentum has waned over the past 15 years, with considerable slippage in cancer survival rankings (eg, the UK is ranked 28th of 33 countries, with similar wealth and income, for 5-year survival with lung and stomach cancer)1 and very poor performance in the International Cancer Benchmarking Partnership cancer policy scorecard.2 At a meeting convened by St George's House (Windsor, UK) in September, 2025, international experts shared experiences of designing and implementing their own plans.

Radiation-induced lung injury is a clinically significant complication induced by thoracic radiotherapy.1 10–20% of patients present with signs of radiation-induced lung injury, which vary widely according to grade and type of cancer and duration of treatment.2

Pirfenidone in combination with glucocorticoids provides a potential therapeutic strategy for grade 2 or grade 3 radiation-induced lung injury, addressing the unmet clinical need for effective antifibrotic therapy in patients receiving thoracic radiotherapy. Further investigation is needed to validate these findings in patients with worse radiation-induced lung injury than was studied here.

Our study met the primary endpoint, showing antitumour activity (clinical complete response rates) and a manageable safety profile for ezabenlimab and mDCF induction when given with INRT in patients with locally advanced SCAC, enabling personalised INRT, and supporting phase 3 trials of this treatment in patients with stage 3 SCAC.

In 2021, the Global Institute of Psychosocial, Palliative, and End-of-Life Care (University of Toronto, Canada) in collaboration with the Institute of Cancer Policy (King's College London, UK) launched a project called Biomedicine and the Soul of Medicine: Optimising the Balance. As part of this project, a multidisciplinary symposium held over 3 days on Palliative Care, Culture, and the Clinic brought together more than 600 registrants from over 60 countries to explore humanistic and culturally relevant dimensions of cancer care, particularly for patients with advanced disease.

Amid unprecedented scientific progress in oncology, a growing body of evidence reveals a parallel and profound crisis in the human experience of cancer care. Despite overall survival outcomes improving, the systems designed to deliver care increasingly fall short in addressing the emotional, relational, and existential dimensions of cancer. Although examples of compassionate and attentive care can be found in every setting, patients and families across global contexts continue to report being unheard, unsupported, and, at times, actively harmed by care structures that prioritise technical precision over human presence.

The success of Europe's Beating Cancer Plan (EBCP) is at risk of being undermined by slow progress on alcohol, tobacco, and nutrition control, according to an implementation findings study published on Oct 20, 2025.

Targeted therapy has entered the stage of glioma management. Mutated isocitrate dehydrogenase (IDH) is the molecular hallmark of WHO grade 2 diffuse low-grade gliomas. In The Lancet Oncology, Timothy F Cloughesy and colleagues compared the mutated IDH inhibitor vorasidenib with placebo for diffuse low-grade gliomas without high-risk features, with 6 months' additional follow-up.1 As expected with the short additional follow-up, this study supports the results of progression-free survival, time to next intervention, and adverse events from the phase 3 trial (INDIGO).

Vorasidenib reduced tumour growth rate and improved seizure control compared with placebo, with no observed negative effects on HRQOL or neurocognition. Additional follow-up supported the robustness of progression-free survival and time to next intervention in patients with grade 2 IDH1/2-mutant diffuse glioma. These findings support the use of vorasidenib in patients with grade 2 IDH1/2-mutant gliomas who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy.

As of Oct 15, 2025, New Zealand has, begun a nationwide extension to its breast cancer screening programme, which will now include women aged 70–74 years as well as those already eligible (aged 45–69 years). This will mean tens of thousands more women will be able to access free mammograms once every 2 years, beginning with those aged 70 and 74 years and then expanded over a 4-year rollout to include women aged 71, 72, and 73.

Health ministers in the Eastern Mediterranean region have officially adopted the Cairo Call to Action on Breast Cancer, uniting governments in the region behind a shared framework to address long-standing inequities in cancer care. The agreement outlines priorities to strengthen primary care screening, improve diagnostic and treatment services, expand psychosocial support, and integrate cancer data systems.

Sara A Hurvitz (Fred Hutch Cancer Center, Seattle, WA, USA) and colleagues presented results from the randomised, open-label, phase 3, VIKTORIA-1 trial in 392 patients with HR+/HER2- advanced breast cancer. Medium progression-free survival was 9·3 months in patients receiving the triplet combination of gedatolisib (180 mg, intravenous, once weekly for 3 weeks), fulvestrant (500 mg, intramuscular, every 2 weeks [cycle 1] then every 4 weeks) and palbociclib (125 mg, once daily for 21 days) compared with 2·0 months (hazard ratio [HR] 0·24; 95% CI 0·17–0·35; p<0·0001) for patients receiving fulvestrant alone and 7·4 months (HR 0·33; 0·24–0·48; p<0·0001) for those receiving the doublet combination of gedatolisib plus fulvestrant.

Myelodysplastic syndromes are a complex and heterogenous group of clonal myeloid neoplasms, characterised by ineffective haematopoiesis, diverse cytopenias, and the risk of progression to acute myeloid leukaemia. Since being identified as a distinct disease in the late 1970s, the journey towards understanding, classifying, and treating myelodysplastic syndromes has been arduous, marked by major advances, yet still hampered by persistent challenges. Today patients with myelodysplastic syndromes continue to face low long-term survival, with a 5-year overall survival rate of approximately 37%, and no curative treatments outside haematopoietic stem-cell transplantation.

Essential thrombocythaemia is a clonal myeloproliferative neoplasm associated with a lifelong risk of arterial and venous thrombosis, haemorrhage, and disease progression to secondary myelofibrosis and acute leukaemia.1 Current management strategies are primarily guided by the estimated risk of thrombotic events, presence of extreme leukocytosis or thrombocytosis, and disease-related symptoms. Hydroxyurea remains the most widely used first-line cytoreductive therapy for essential thrombocythaemia.

Anti-CD19 CAR T-cell therapy has established a new standard of care for children and adults with relapsed or refractory B-cell acute lymphoblastic leukaemia (r/r B-ALL), culminating in the regulatory approval of three products associated with high rates of remission.1–3 However, the promise of currently available commercial CAR T-cell agents has been constrained by the loss of CAR persistence, resulting in suboptimal durability and high rates of CD19-positive relapse. Innovative approaches to circumvent this limitation include the development of armoured CAR T cells, in which the T cells are engineered to secrete immunomodulatory cytokines.

Yin W, Yan X, Cai J, et al. Incidence, mortality, and survival associated with acute leukaemia subtypes by age group in China: a population-based cancer registry analysis and cohort study. Lancet Haematol 2025; 12: e808–22—The appendices of this Article have been updated as of Nov 3, 2025.

The Global Burden of Disease (GBD) study represents an incredible source of information to quantify and understand the magnitude and impact of all conditions, including common and rare diseases, on patients’ quality of life, mortality, and morbidity. Emerging evidence suggests that detailed national studies are needed to inform, calibrate, and validate GBD estimates. This need is also supported by action on local GBD network, such as the Italian GBD network, cross-talking with the global GBD network.

TikTok is a rapidly growing social media platform on which users develop, interact with, or share short vertical videos (TikToks). Although TikToks have immense potential to be harnessed to affect health knowledge, attitudes, and behaviours, little research guides TikToks’ potential public health applications. Since 2020, we have led the development and use of a large TikTok library to engage diverse young adults to haematopoietic stem-cell donation. This library, including hundreds of TikToks starring diverse performers, has generated hundreds of thousands of views and engagements across social media platforms.

Our findings suggest that ropeginterferon alfa-2b could be considered as a second-line treatment option for patients with essential thrombocythaemia and leukocytosis.

Patients with relapsed or refractory multiple myeloma treated with belantamab mafodotin, pomalidomide, and dexamethasone or bortezomib, pomalidomide, and dexamethasone reported stable HRQOL. Self-reported ocular adverse events were generally manageable and minimally bothersome within the first year of treatment. These findings indicate that belantamab mafodotin, pomalidomide, and dexamethasone is well tolerated, with little detriment to HRQOL, supporting its use in relapsed or refractory multiple myeloma.

Enasidenib plus venetoclax is safe, with no unexpected TEAEs or treatment-related deaths, and shows preliminary activity in patients with relapsed or refractory IDH2-mutated AML and MDS.

META 10-19 showed a manageable safety profile and promising antileukaemic activity in patients with relapsed or refractory B-cell acute lymphoblastic leukaemia at low doses, highlighting that IL-10 engineering is a potential strategy for optimising CAR T-cell therapy in this patient group.

The global population is ageing and this demographic shift has profound effects on haemostasis, notably a progressive tilt towards a hypercoagulable state. A major age-associated change in haemostasis is the increase in von Willebrand factor (VWF), a plasma glycoprotein essential for primary and secondary haemostasis. VWF deficiency causes von Willebrand disease, which is the most common inherited bleeding disorder and affects approximately 1% of the population. Conversely, elevated VWF concentrations are linked to increased thrombotic risk; VWF concentrations increase with age by approximately 10–15 IU/dL per decade.

This Viewpoint issues a multidisciplinary call to embed sustainability into anticoagulation care, aligning clinical excellence with climate responsibility. Anticoagulation management—including drug manufacturing, laboratory diagnostics, therapeutic monitoring, and long-term follow-up—contributes substantially to health-care-associated carbon emissions. We propose a systems-level decarbonisation strategy, anchored in life cycle assessment methodology, to quantify emissions across anticoagulation care and identify high-impact intervention points.

A 7-month-old boy presented to Osaka City General Hospital, Osaka, Japan, with persistent thrombocytopenia since birth. Despite treatments including intravenous immunoglobulin, prednisolone, romiplostim, and rituximab (details provided in the appendix p 1), platelet counts remained at approximately 20–30 × 109 platelets per L (normal range 158–348 × 109 platelets per L). A blood transfusion was administered when the platelet count fell below 5 × 109 platelets per L. After platelet transfusions, the platelet count could be maintained for several days.

Gene therapy is entering routine clinical practice for patients with sickle cell disease due to the most common genetic subtypes, hemoglobin S (HbS) gene homozygotes and HbS-β⁰ thalassemia. Wilks et al provide a perspective on why gene therapy should also be considered for patients with severe sickle cell disease due to compound heterozygosity for HbS and HbC (HbSC).

Myeloid cells in the bone marrow are increasingly recognized as modulators of malignant cell behavior. Using patient multiple myeloma samples and murine models, Rivera et al demonstrate that aberrant mature neutrophil populations can promote myeloma by inhibiting T-cell proliferation and that this can be therapeutically reversed by CXC chemokine receptor 2 (CXCR2) inhibition. These data illuminate the complexity of interactions between myeloma cells and different cells within the bone marrow microenvironment.

The combination of obinutuzumab for 8 infusions and venetoclax for 1 year is a standard first-line therapy for patients with chronic lymphocytic leukemia (CLL). Through rigorous comparison across 2 sequential German CLL study group randomized trials, Al-Sawaf and colleagues demonstrate that outcomes with this regimen are excellent, regardless of fitness status. Safety and efficacy are similar between patients with cumulative illness rating scale scores of >6 or reduced creatinine clearance (unfit patients) and those fit patients with neither. Unfit patients require more dose reductions, but these do not impact efficacy unless venetoclax dosing is reduced by more than 30%. These data reinforce the applicability of this regimen for most patients with CLL requiring initial therapy.

The activating mutation JAK2V617F causes clonal hematopoiesis and myeloproliferative neoplasms (MPNs) but can be present in a minority of cells. Using an immunocompetent murine model of low-level chimerism, Bonal et al addressed how small clones of cells with JAK2V617F cause disease. They show that JAK2V617F cells significantly affect the bone marrow microenvironment and unmutated hematopoiesis, together skewing the whole hematopoietic system toward an MPN-like phenotype. These data help explain MPN development and why some clinical features may persist despite effective reductions in JAK2V617F clone size with therapy.

Congenital thrombotic thrombocytopenic purpura (cTTP) is the hereditary form of TTP and is characterized by biallelic mutations in ADAMTS13 resulting in severe ADAMTS13 deficiency. Stubbs et al provide detailed longitudinal follow-up data for nearly 100 patients from a multiethnic registry in the United Kingdom, reporting 16 new ADAMTS13 variants. Postdiagnosis prophylaxis with plasma products or recombinant ADAMTS13 reduces recurrences and end-organ damage, including stroke and renal dysfunction.

Obesity increases the risk of venous thrombosis and is commonly associated with an increase in plasma levels of plasminogen activator inhibitor 1 (PAI-1), a key inhibitor of fibrinolysis. Li et al report that tropifexor, an experimental farnesoid X receptor (FXR) agonist, reduces obesity-associated impairment of fibrinolysis through modulation of hepatic PAI-1 expression in murine models of venous thrombosis. Clinical studies will be necessary to assess the therapeutic potential of targeting the FXR/PAI-1 pathway to improve fibrinolysis and reduce deep vein thrombosis risk.

Patients in intensive care with an acute illness associated with systemic inflammation are known to be at highest risk for transfusion-related acute lung injury (TRALI). This is speculated to be because TRALI seems to be a “2-hit” phenomenon, with transfusion being the second hit and inflammation the first. Rebetz and colleagues investigated mechanisms underpinning the first hit in elegant murine models, finding that mitochondrial DNA stimulates recipient Toll-like receptor 9 (TLR9) to instigate pulmonary damage, with TLR9 antagonism preventing murine TRALI. These data increase our understanding of how TRALI develops and provide a novel therapeutic target to reduce TRALI in patients.

These findings demonstrate the heterogeneity of preferences and support individualized discussion of treatment goals relating to risk‐reducing surgical planning.

Urinary HPV testing exhibits lower sensitivity than both cervical professional sampling and vaginal self‐sampling. Although its noninvasive nature supports its potential utility as a complementary strategy in resource‐limited or culturally conservative populations, it is not currently suitable for general population screening where standard methods are available because of its suboptimal performance and lack of standardized protocols for sampling and testing. Furthermore, standardization of sampling and testing protocols is required before routine implementation.

CMML in patients aged 50 years and younger is rare and presents with unique clinical and mutational features, suggesting a distinct pathogenesis.

MYC amplification and high protein expression both independently and concurrently predict poor survival in pediatric and young adult osteosarcoma, beyond metastatic status. Incorporating MYC status into risk stratification may enhance prognostic accuracy and inform targeted therapeutic development.

3G‐TKI with azacitidine is an effective and safe therapy providing more chance to receive a transplantation for CML in myeloid blast phase. Potential biomarkers associated with outcomes were identified.

Among MLWH, HPV16 E6 antibodies are strongly associated with OPSCC, yet point estimates of the sensitivity and specificity of HPV16 E6 antibodies for OPSCC were lower compared to studies in populations without HIV.

These contemporary data reflect treatment patterns since 2000, which show an elevated risk of subsequent breast tumors in either breast among Black women after DCIS.

Mild dilation of the main pancreatic duct without an apparent obstructing mass may be an independent risk factor for neoplastic progression to pancreatic cancer in high-risk individuals, according to findings from an analysis published in Gastro Hep Advances. 

In an interim analysis of an Australian single-center phase I/II trial (AlphaBet) reported in The Lancet Oncology, Kostos et al found that the combination of lutetium Lu-177–labeled PSMA–I&T (LuPSMA-I&T) and the bone-seeking alpha-emitter radium Ra-223 dichloride (Ra-223) was active in...

The addition of the PD-1 inhibitor pembrolizumab to weekly paclitaxel, with or without the VEGFA-targeted bevacizumab, significantly improved progression-free survival and overall survival in patients with platinum-resistant recurrent ovarian cancer, in the randomized, double-blind, phase III...

Stereotactic radiation therapy (SABR) was found to be noninferior to surgical resection in terms of overall survival for patients with early-stage non–small cell lung cancer (NSCLC), according to 10-year results from the STARS trial presented at the American Society for Radiation Oncology (ASTRO)...

The University of Texas MD Anderson Cancer Center has launched its historic $2.5 billion comprehensive philanthropic campaign, Only Possible Here, The Campaign to End Cancer. The campaign represents the largest fundraising effort in MD Anderson's 84-year history, bringing together philanthropic...

As reported in the Journal of Clinical Oncology by Ratan et al, long-term follow-up in the phase III DeFi trial has shown maintained benefits with prolonged nirogacestat treatment in patients with desmoid tumors.

The U.S. Food and Drug Administration (FDA) has approved pertuzumab-dpzb (Poherdy) as an interchangeable biosimilar to pertuzumab (Perjeta). This is the first approval of a biosimilar for pertuzumab.

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

In an individual-patient pooled analysis reported in the Journal of Clinical Oncology, Raimondi et al found that neoadjuvant treatment with dual CTLA-4/PD-(L)1 immune checkpoint inhibitors (ICIs) was associated with higher pathologic response rates vs perioperative FLOT (fluorouracil, leucovorin,...

The addition of the PD-L1–targeting monoclonal antibody durvalumab to conventional perioperative chemotherapy with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) resulted in a statistically significant and clinically meaningful improvement in overall survival, with benefit seen...

In a French phase II trial reported in The Lancet Oncology, Kim et al found that the combination of the PD-1 inhibitor ezabenlimab and induction chemotherapy with modified docetaxel, cisplatin, and fluorouracil (mDCF) and adaptive chemoradiotherapy was active in patients with treatment-naive stage...

Based on the results of a multicenter cross-sectional survey study published in JAMA Network Open by Raman et al, patients with blood cancer who were potentially hospice-eligible placed the greatest importance on transfusion access compared with routine hospice services.

A systematic review and meta-analysis published in JAMA Network Open found first-line PARP inhibitor maintenance after platinum-based chemotherapy was linked to improved progression-free survival across multiple patient populations with advanced-stage epithelial ovarian cancer. However, according...

Researchers have discovered that an isoform of the transcription factor RUNX1 orchestrates chemoresistance in patients with acute myeloid leukemia (AML), according to findings published in Blood Cancer Discovery. They identified that the long-isoform RUNX1C's connection to BTG2 may enable cellular...

Supervised aerobic and resistance exercise can improve the physical performance and strength of patients living with metastatic breast cancer, according to new data from the PREFERABLE-EFFECT study that was presented by Anne May, PhD, during the Advanced Breast Cancer Eighth International Consensus ...

Most cancer clinic staff prefer a team-based approach to supportive cancer care services over a technology-based approach, according to the results of a mixed-methods study of supportive care perceptions that was published in JNCCN—Journal of the National Comprehensive Cancer Network. The study...

In a phase III trial (TRYBECA-1) reported in the Journal of Clinical Oncology, Hammel et al found that the addition of eryaspase (suspension of erythrocytes encapsulating L-asparaginase) to chemotherapy did not significantly improve outcomes in second-line treatment of patients with advanced...

The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced that Richard Pazdur, MD, has been appointed Director of the Center for Drug Evaluation and Research (CDER). Dr. Pazdur is a 26-year veteran of the FDA and the Founding Director of its...

As reported in The New England Journal of Medicine by Tolaney et al, interim analysis of the phase III DESTINY-Breast09 trial has shown significantly improved progression-free survival with fam-trastuzumab deruxtecan-nxki (T-DXd) plus pertuzumab vs a taxane (paclitaxel or docetaxel), trastuzumab,...

Osimertinib in combination with local consolidative therapy of radiation and/or surgery led to a significant extension of progression-free survival for patients with EGFR-mutant metastatic non–small cell lung cancer (NSCLC), according to findings from the phase II NorthStar trial presented at the...

The combination of osimertinib plus chemotherapy led to a median overall survival of 47.5 months compared with 37.6 months with osimertinib monotherapy in patients with EGFR-mutated advanced non–small cell lung cancer (NSCLC) who had not received prior treatment for advanced disease, according to...

The introduction of artificial intelligence (AI) to assist colonoscopies may be linked to a reduction in the ability of endoscopists to detect adenomas in the colon without AI assistance, according to a paper published by Budzyń et al in The Lancet Gastroenterology & Hepatology.

After 2 decades of practicing medicine across multiple disciplines and health systems, I’ve witnessed the dramatic transformation of patient-physician interactions, and none more dramatic than what I’m seeing in this era of artificial intelligence (AI) and its impact on cancer care. Early in my...

In the phase II TUXEDO-3 trial—reported in two articles in The Lancet Oncology—Fuereder et al and Bartsch et al found that the topoisomerase-1 HER3-targeting antibody-drug conjugate patritumab deruxtecan (HER3-DXd) was active in cohorts of patients with active brain metastases from advanced...

Almost half of all women (48%) under the age of 40 who are living with advanced breast cancer have children under the age of 18, and 64% of these young patients also experience employment disruptions after they are diagnosed, according to findings from a survey conducted by the Young Survival...

ABC Global Alliance's landmark Advanced Breast Cancer Global Decade Report 2015–2025 was recently released and published in The Breast. The report highlights significant advancements made over the past decade that have transformed care for patients with advanced breast cancer, but also reveals gaps ...

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.

Third-generation EGFR tyrosine kinase inhibitors such as osimertinib have substantially improved clinical outcomes in advanced-stage EGFR-mutant non-small-cell lung cancer, but resistance remains inevitable. In this Review, the authors discuss biomarker-directed and biomarker-unselected approaches to overcome established resistance to osimertinib, as well as pre-emptive upfront strategies to delay or prevent the occurrence of osimertinib resistance.

A better understanding of the development and progression of heterogeneity in oesophageal adenocarcinoma and its precursor condition, Barrett oesophagus, is crucial for improving surveillance and treatment strategies. The authors of this Review outline the current knowledge of the causes, mediators and therapeutic implications of spatial and temporal heterogeneity in these diseases.

T-DXd shows promise in neoadjuvant therapy for HER2⁺ breast cancer

Radiomics Quality Score 2.0: what changed from version 1.0 and why it matters

Reply to ‘Radiomics Quality Score 2.0: what changed from version 1.0 and why it matters’

From the ESMO Congress 2025

Dormant tumour cells that survive initial therapy can awaken years later to seed metastases. New data from a phase II trial indicate that intercepting this dormancy by targeting autophagy and mTOR signalling might prevent breast cancer relapse before it begins, opening a path towards proactive prevention disease recurrence.

Domvanalimab plus zimberelimab shows promise in upper-tract cancers

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Korro Bio is moving back to square one as a preclinical biotech after the failure of KRRO-110 in alpha-1 antitrypsin deficiency. The company’s stock is down 80% on all the news.

The mid-stage failure was unexpected to analysts at BMO Capital Markets, who viewed ‘770 as mostly derisked given its similar mechanism of action to Johnson & Johnson’s Spravato.

A new generation of companies is eyeing the existing, sizeable hair loss market, hoping that better formulations and new scientific targets will finally produce treatments that are safer and more effective, as well as commercially successful.

The highest dose of Eli Lilly’s eloralintide led to 20.1% weight loss after 48 weeks in a Phase II trial, exceeding analyst expectations and highlighting a “potentially best in class profile,” according to BMO Capital Markets.

In this episode presented by PII, BioSpace’s head of insights discusses how to relieve clinical trial patients of technological burden to improve compliance with guests Oliver Eden and Travis Webb.

Two patients experienced grade 3 liver enzyme elevations that were deemed related to Terns’ investigational obesity pill TERN-601.

In this episode presented by PII, BioSpace’s head of insights discusses decentralized clinical studies and how connected technology can improve patient compliance with guests Oliver Eden and Travis Webb.

Regeneron is aiming to file a regulatory application for DB-OTO by the end of the year.

Moderna’s mRNA-4359, when used with Keytruda, achieves a 24% overall objective response rate in patients with melanoma, with efficacy increasing to 67% in those positive for PD-L1.

Sanofi’s Orano Med-partnered radioligand therapy AlphaMedix achieved all primary efficacy endpoints, which included a measure of overall response rate, in the mid-stage ALPHAMEDIX-02 study.

Cogent Biosciences expects to file a new drug application for bezuclastinib in gastrointestinal stromal tumors early next year after what Leerink said was “the first positive trial in this disease in over a decade.”

The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.

Multiple analyst firms were impressed by the Phase III data, which showed that Merck’s oral PCSK9 inhibitor can lower low-density lipoprotein cholesterol by more than 55% after 24 weeks.

In this episode presented by PII, BioSpace’s head of insights discusses how to relieve clinical trial patients of technological burden to improve compliance with guests Oliver Eden and Travis Webb.

To expand the population for the anti-amyloid Alzheimer’s drugs, Lilly and Biogen are testing presymptomatic patients. Will doctors be open to this paradigm-shifting change?

With a 100% response rate in a Phase II study, KYV-101 sets a new efficacy bar in generalized myasthenia gravis, according to analysts at William Blair.

Already sky high after the success of its limb-girdle muscular dystrophy therapy, reported on Monday, BridgeBio’s shares rose nearly 8% more as encaleret balanced calcium levels in patients with a genetic thyroid disorder.

Phase III data for dapirolizumab pegol presented at the 2025 conference of the American College of Rheumatology showed quality-of-life benefits in systemic lupus erythematosus that could see Biogen go head-to-head with GSK and AstraZeneca in a blockbuster space.

A key question for investors going forward will be whether Moderna’s other latent virus vaccines for Epstein-Barr and shingles can succeed after the failure of the CMV program.

The company is dropping its social anxiety disorder program but will still test the molecule in post-traumatic stress disorder.

Korro Bio is moving back to square one as a preclinical biotech after the failure of KRRO-110 in alpha-1 antitrypsin deficiency. The company’s stock is down 80% on all the news.

The mid-stage failure was unexpected to analysts at BMO Capital Markets, who viewed ‘770 as mostly derisked given its similar mechanism of action to Johnson & Johnson’s Spravato.

Cogent Biosciences expects to file a new drug application for bezuclastinib in gastrointestinal stromal tumors early next year after what Leerink said was “the first positive trial in this disease in over a decade.”

The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.

Multiple analyst firms were impressed by the Phase III data, which showed that Merck’s oral PCSK9 inhibitor can lower low-density lipoprotein cholesterol by more than 55% after 24 weeks.

A new generation of companies is eyeing the existing, sizeable hair loss market, hoping that better formulations and new scientific targets will finally produce treatments that are safer and more effective, as well as commercially successful.

The nausea and other gastrointestinal side effects of weight loss drugs like Novo Nordisk’s Wegovy or Eli Lilly’s Zepbound will limit how much these drugs can help patients and stunt the overall obesity market unless we approach the problem head on.

The highest dose of Eli Lilly’s eloralintide led to 20.1% weight loss after 48 weeks in a Phase II trial, exceeding analyst expectations and highlighting a “potentially best in class profile,” according to BMO Capital Markets.

In this episode presented by PII, BioSpace’s head of insights discusses how to relieve clinical trial patients of technological burden to improve compliance with guests Oliver Eden and Travis Webb.

To expand the population for the anti-amyloid Alzheimer’s drugs, Lilly and Biogen are testing presymptomatic patients. Will doctors be open to this paradigm-shifting change?

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

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

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

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

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

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

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

On September 25, 2025, the Food and Drug Administration approved imlunestrant (Inluriyo, Eli Lilly and Company), an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

On September 19, 2025, the Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda, Merck). See the prescribing information for the specific indications.

On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN.

On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.

On August 8, 2025, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, 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-approved test, and who have received prior systemic therapy.

On August 6, 2025, the Food and Drug Administration granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals, Inc.), a protease activator, for adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.

On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

On July 2, 2025, the Food and Drug Administration granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.

On June 23, 2025, the Food and Drug Administration granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.

On June 18, 2025, the Food and Drug Administration approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).  

On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin after surgery, and then as a single agent.

On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

On June 3, 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA previously approved darolutamide in combination with docetaxel for mCSPC.

On May 15, 2025, the Food and Drug Administration approved retifanlimab-dlwr (Zynyz, Incyte Corporation) with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The FDA also approved retifanlimab-dlwr, as a single agent, for adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.

On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.

On May 14, 2025, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). This represents the first FDA approval of an oral therapy for PPGL.

Nature. 2025 Nov 12. doi: 10.1038/s41586-025-09745-x.
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