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Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

Journal of Clinical Oncology, Ahead of Print.

In NSCLC with EGFR exon 20 insertions, first-line sunvozertinib led to longer progression-free survival than chemotherapy. The most common adverse events of grade 3 or higher were elevated creatine kinase, diarrhea, and anemia.

This review summarizes the pathogenesis and treatment of myeloproliferative neoplasms, highlighting the role of driver mutations, inflammation, and emerging targeted therapies that may achieve durable disease modification.

A proposed reclassification of medical marijuana products as Schedule III drugs would address only two of the three key barriers to research on marijuana’s safety and effectiveness for various indications.

An 82-year-old man was brought to the ED after being “found down.” One week earlier, he had returned from a 1-month visit to Chad. A peripheral-blood smear showed ring-form trophozoites within erythrocytes.

Among patients with RET fusion–positive non–small-cell lung cancer, adjuvant selpercatinib led to longer event-free survival than placebo. Adverse events of grade 3 or higher included elevated liver-enzyme levels.

Talquetamab–daratumumab, with or without pomalidomide, led to longer progression-free survival than daratumumab-based standard care in relapsed or refractory myeloma. More than 75% of patients had grade 3 or higher adverse events.

A 55-year-old man with a smoking history of 10 pack-years presented with 2 years of an enlarging, painless lump below his right ear. A previously unnoticed smaller mass in the left parotid gland was seen on examination.

A 61-year-old man with prolonged neutropenia after chemotherapy for AML was evaluated for persistent fever despite antimicrobial therapy. Physical examination was notable for a skin macule with central necrosis on the chest.

In a child with advanced nephroblastoma, T-cell therapy targeting preferentially expressed antigen in melanoma led to a 69% tumor reduction, with molecular, metabolic, and histologic evidence of complete remission at 200 days.

In high-risk localized prostate cancer, ADT plus apalutamide led to a pathological complete response or minimal residual disease and 5-year metastasis-free survival in a greater percentage of patients than ADT plus placebo.

Current curative-intent management of high-risk localized prostate cancer (nonmetastatic prostate cancer with extraprostatic extension or seminal-vesicle invasion, a histologic Gleason score of ≥8 [on a scale from 6 to 10, with higher scores indicating more aggressive disease], or a serum prostate-specific antigen level of ≥20 ng per milliliter) involves either...

A 60-year-old woman with stage II triple-negative breast cancer presented to the ED with a weeklong history of fevers, rigors, malaise, nonproductive cough, and nausea.

In patients with metastatic prostate cancer with gene alterations, talazoparib–enzalutamide led to better progression-free survival outcomes than placebo–enzalutamide but with more serious adverse events.

In relapsed multiple myeloma, teclistamab improved 18-month progression-free survival as compared with standard therapy. Grade 3 or 4 infections were common; antimicrobial prophylaxis and immune globulin support were recommended.

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

The treatment of advanced prostate cancer has undergone significant improvements, with two developments proven to be especially transformative. The first advance was the establishment of treatment intensification in patients with metastatic castration-sensitive prostate cancer (hereafter referred to as metastatic androgen pathway modulation–sensitive [APMS] disease, in accordance with the recently updated...

The treatment landscape of multiple myeloma has undergone a profound transformation over the past two decades, driven by deeper insights into disease biology, refined patient stratification, the integration of new prognostic biomarkers, and sustained therapeutic innovation. Today, most patients receive proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies as frontline...

This study supports enzymatic cross-correction of neurons and oligodendrocytes by atidarsagene autotemcel, a gene therapy that prevents or slows neurodegeneration in children with early-onset metachromatic leukodystrophy.

Among cisplatin-eligible patients with muscle-invasive bladder cancer undergoing cystectomy, perioperative enfortumab vedotin–pembrolizumab led to significantly better event-free survival outcomes than cisplatin–gemcitabine.

Among patients with previously treated metastatic pancreatic ductal adenocarcinoma, the RAS(ON) inhibitor daraxonrasib led to significantly longer overall survival and progression-free survival than chemotherapy.

In Germany, politicians are pressing the government to end discrimination against people in remission from cancer. Germany remains among the European outliers in obstructing a fresh start for former patients. A petition campaigning under the slogan, “Healed. And Yet Disadvantaged”, has gathered over 56 000 signatures.

The adoption of total mesorectal excision (TME) has significantly reduced the risk of locoregional recurrence in patients with rectal cancer. However, this reduction comes at the cost of substantial treatment-related morbidity, including permanent stoma formation and long-term impairment of bowel, urinary, and sexual function that adversely impact quality of life (QOL) and functionality.1 As such, management has evolved toward risk-adapted, patient-centred strategies, including selective organ preservation that is oncologically safe and associated with better QOL.

Can a modest increase in radiotherapy dose make a difference for a patient with high-risk prostate cancer? In The Lancet Oncology, Christophe Hennequin and colleagues present results from the GETUG-AFU 18 trial,1 which enrolled 505 patients across 25 centres in France to answer this important and relevant question. Participants were randomly assigned (1:1) to receive 70 Gy or 80 Gy to the prostate, along with 3 years of androgen deprivation therapy (ADT). The higher radiotherapy dose improved biochemical or clinical progression-free survival (the primary outcome) from 88·1% to 91·4% at 5 years and from 72·2% to 83·6% at 10 years (stratified hazard ratio 0·56, 95% CI 0·40–0·78).

Stromal tumour-infiltrating lymphocytes (sTILs) have become one of the most clinically informative immune biomarkers in breast cancer,1 associated with improved response to systemic therapy and favourable long-term outcomes.2,3 Reproducibility is not the obstacle to their use. In a secondary analysis of the APHINITY trial in The Lancet Oncology, Luis E Lara González and colleagues4 found a high interobserver reproducibility among five pathologists scoring 262 cases to international guidelines.5 However, scoring requires expert pathologists, quality-assured haematoxylin and eosin slides, and time, which are unevenly distributed across health systems.

Non-communicable diseases (NCDs) already account for an estimated 43% of all deaths in Afghanistan1 and are projected to exceed 60% by 2030, mainly among women. However, access to cancer care remains critically limited—Afghanistan has only two functioning cancer treatment centres, both in Kabul (Jamhuriat Hospital and the newly opened National Cancer Diagnosis and Treatment Hospital), for more than 40 million people, and neither offers radiotherapy.2 These gaps contribute to delayed diagnosis, poor outcomes, and avoidable mortality, and highlight the urgent need to strengthen cancer prevention, detection, and treatment nationwide.

Canada's cancer care system has achieved substantial progress through advances in cancer prevention, screening, early detection, and treatment, including targeted therapies and immunotherapy.1 Although both the age-standardised incidence rate and age-standardised mortality rate (ASMR) continue to decline, an estimated 254 100 Canadians will be diagnosed with cancer and an estimated 87 900 will die from the disease in 2026.2

We welcome The Lancet Oncology Commission highlighting the global cancer workforce crisis, which projects a shortage of 9·47 million diagnostic (pathology and imaging) specialists in Asia by 2050 and identifies pathologists as yielding the highest return on investment in the region (US$35·4 per $1 invested).1 Although the Commission focuses primarily on Africa and Latin America, southeast Asia offers a compelling example of how diagnostic workforce shortages and limited laboratory capacity directly constrain access to precision oncology.

Brunt AM, Cafferty FH, Kirby AM, et al. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 10-year efficacy and late normal tissue effects from a multicentre, open-label, non-inferiority, phase 3, randomised controlled trial and 5-year efficacy results from a randomised axillary substudy. Lancet Oncol 2026; 27: 686–98—The appendix of this Article has been corrected as of Aug 24, 2026.

The UK Government has announced it is to conduct a study into cancer risk in armed services personnel, both past and present. The UK's Ministry of Defence says the study is part of its efforts to improve the long-term health of those who serve and have served in the armed services. The UK-wide epidemiological study (covering all four nations) will examine cancer incidence among those who have served since 1990, including some 1·4 million currently serving and veterans. No personnel will need to take action to be included in the study, as it will use existing records held in by the country's National Health Service (NHS).

On July 23, 2026, the Government of Sweden announced plans to prohibit perfluoroalkyl and polyfluoroalkyl substances (PFAS), also called forever chemicals, in certain consumer products such as clothing, footwear, cosmetics, and kitchen utensils starting Jan 1, 2028. This plan will make Sweden one of the latest European countries to propose national restrictions ahead of the broader EU legislation.

The Caribbean Community (CARICOM) is moving towards a regional framework for cancer care after calling for stronger cooperation between members, although questions remain over funding, governance, and implementation. The call followed the 14th Annual Caribbean Association for Oncology and Hematology (CAOH) Scientific Conference, held in Trinidad and Tobago, on July 17–19, 2026.

On July 28, 2026, organisations from the UK and Japan announced a partnership that will provide funding opportunities for international collaborative clinical trials aimed at developing innovative treatments for cancers affecting children and young people (CYP).

Europe is set to miss the WHO target to eliminate viral hepatitis as a public health threat by 2030 despite progress in screening because of gaps in vaccination and reaching key populations, according to the European Centre for Disease Prevention and Control (ECDC).

A new medicine for hepatocellular liver cancer has been granted an Innovation Passport through the UK's Innovative Licensing and Access Pathway (ILAP), the Medicines and Healthcare products Regulatory Agency (MHRA) announced last week.

The eastern Caribbean island nation of Saint Lucia has launched a national population-based cancer registry, 7 years after first announcing plans to establish one, as it seeks to replace fragmented records and modelled estimates with systematic data on cancer incidence. The registry comes as the country develops a cancer control plan, but its usefulness will depend on complete case reporting, specialist staff, sustained financing, and whether the resulting data influence policy making.

Cuba's cancer care programme is facing a polycrisis, in which disruptions in energy supply, pharmaceutical access, and technological capacity interact and reinforce one another. The strain is most visible at two of its most resource-intensive nodes: the supply of cytostatic drugs for chemotherapy and the operational readiness of radiotherapy. Both have long been limited by restricted access to pharmaceutical markets, equipment, and spare parts under the decades-long US trade embargo. The oil blockade imposed on Jan 29, 2026 (figure 1), has converted these chronic constraints into an acute systemic breakdown.

When I received my first chemotherapy tablets, the literature was terrifying: the insert warned against touching the pills or my bodily fluids without gloves. The bag read CAUTION next to a neon yellow biohazard symbol. Shared bathrooms were discouraged. I thought: if this treatment is so dangerous, why am I supposed to ingest it?

STRIDE plus lenvatinib plus TACE showed a statistically significant progression-free survival improvement versus TACE. These findings support a STRIDE-based regimen as a potential new treatment option for people with embolisation-eligible HCC; additional follow-up is being conducted for final analysis of overall survival across treatment groups.

Ivonescimab plus chemotherapy showed a clinically meaningful and statistically significant progression-free survival benefit in patients with EGFR-mutated NSCLC after progression on EGFR-TKI therapy. The clinical benefit and lack of new safety signals of ivonescimab with chemotherapy support the potential for the combination as a new treatment option in this patient population.

For patients with resected ALK-positive NSCLC, adjuvant alectinib had a manageable safety profile; HRQoL improved and was maintained over 2 years of active treatment. Together with the disease-free survival benefit seen in ALINA, these data support adjuvant alectinib as an important new standard-of-care for patients with resected ALK-positive NSCLC.

These early results support a response-adapted organ-preservation approach, with LCCRT appearing more effective than SCRT at 12 months. Organ-preservation might also reduce treatment-related toxicity compared with primary TME. Longer follow-up is needed for the prespecified 30-month endpoint and definitive functional and oncological outcomes.

The combination of ifebemtinib and garsorasib showed promising anticancer activity and manageable safety profile in previously treated patients with KRASG12C-mutated metastatic colorectal cancer. Although the improvement in response rate did not reach statistical significance in the randomised study, these findings support further evaluation of ifebemtinib plus garsorasib in this population.

SHR-A2102 demonstrated a safety profile consistent with its topoisomerase I inhibitor payload and showed promising activity in patients with various advanced solid tumours who had previously received anti-cancer treatment. A range of active dose was identified in various tumour types. Several trials are ongoing to evaluate SHR-A2102, either as monotherapy or in combination, in advanced solid tumours.

For patients with high-risk prostate cancer, radiotherapy at a total dose of 80 Gy, in combination with long-term ADT, improved progression-free survival and could be a potential option in this situation. However, given the low number of events, further research is needed to consolidate and confirm the benefit in dose-escalation in prostate cancer-specific survival and overall survival.

Standardised manual sTIL scoring was reproducible, and digital and AI-based methods showed consistent prognostic stratification and potential for treatment-benefit stratification despite only modest correlation between platforms. AI spatial metrics provided complementary information beyond sTIL density and could support more scalable immune assessment. Future studies are needed to validate these approaches in independent cohorts and to clarify their clinical utility for stratifying contemporary HER2-directed therapies.

Two cTIL models deployed entirely without retraining or modification provided statistically significant prognostic information and improved risk discrimination compared with clinicopathological variables alone in this large, platform-based, independent validation study. Although cTIL score did not incrementally improve prognostication compared with models combining clinicopathological variables with sTIL score, these findings support the application of cTILs as a reproducible prognostic biomarker, particularly in settings where routine or widespread pathologist assessment is unavailable.

Management of second ipsilateral breast cancer events (iBCEs) remains controversial, and there is a need to collate existing evidence and international guidance on patient selection and local treatment strategies. This project, endorsed by US and European surgical and radiation oncology societies, aimed to gather expert consensus on these issues. A questionnaire on second iBCE local treatment was developed and reviewed by a core group of eight experts, and Delphi methodology was applied over two rounds to 36 panellists, including radiation oncologists, breast surgeons, a plastic surgeon, and medical physicists.

Tumour-infiltrating lymphocytes (TILs) are prognostic and predictive biomarkers in breast cancer. High pre-treatment TILs are associated with a favourable prognosis and improved response to systemic therapies. However, the role of TILs in mediating response to radiotherapy in breast cancer remains underexplored, with scarce clinical evidence to date. In this Review, we present an overview of current evidence and potential mechanisms, highlight opportunities for integrating TILs into radiation oncology trials and clinical practice, and call for standardised TIL reporting to accelerate biomarker-driven individualisation of radiotherapy in breast cancer.

The oligometastatic disease classification system, developed within the European Society for Radiotherapy and Oncology (ESTRO)–European Organisation for Research and Treatment of Cancer (EORTC) OligoCare project, has been proposed for prognostic stratification and clinical trial design across solid tumours. Its application to ovarian cancer, however, is challenged by two disease-specific features: early and often diffuse peritoneal spread and the difficulty of lesion enumeration when peritoneal deposits are not discretely measurable.

The burden of MBC is increasing across Europe, particularly in the Central region, with huge regional differences. Population growth and variations over time impacted on the metrics. Even with a composite European scenario, the mortality‐to‐incidence ratio markedly declined in the three areas.

Medicaid was associated with a lower likelihood of ASCT and was more prevalent among Black patients. Reduced receipt of ASCT was linked to inferior survival, contributing to survival disparities. Within this treated cohort, Medicaid expansion did not improve coverage, ASCT receipt, or survival, suggesting that structural barriers beyond insurance persist. Targeted efforts to improve ASCT access among Medicaid‐insured patients are needed.

Wide variation in cancer risk within the Asian American and NHPI population highlights the critical need for disaggregated data to effectively target cancer prevention and control interventions.

Vimseltinib had a manageable safety profile, demonstrated durable antitumor activity, and provided functional and symptomatic improvements in patients with TGCT, offering an effective treatment option regardless of previous treatment with anti‐CSF1/CSF1R agents.

This randomized clinical trial examines the efficacy, safety, and patient-reported outcomes of adding serplulimab to chemotherapy for patients with extensive-stage small cell lung cancer.

This systematic review and meta-analysis estimates the frequency of reported second primary malignant neoplasms after T-cell–engaging bispecific antibody therapy and evaluates whether study-level characteristics and reporting definitions influence observed estimates.

This nonrandomized clinical trial evaluates the efficacy and tolerance of single-fraction stereotactic body radiotherapy in men with localized prostate cancer.

This cohort study explores the long-term outcomes of patients with platinum-sensitive recurrent ovarian cancer who have exceptional response to poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitors.

This randomized clinical trial evaluates the efficacy and safety of fovinaciclib plus an aromatase inhibitor as first-line treatment for hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer.

This nonrandomized clinical trial aims to determine the efficacy and toxicity profile of a reduced preoperative radiotherapy dose in patients with myxoid liposarcoma.

This secondary analysis of a randomized clinical trial evaluates 5-year outcomes and characterizes circulating tumor DNA dynamics in patients with

This Special Communication provides consensus recommendations on the acquisition, interpretation, and reporting of prostate magnetic resonance imaging for cancer screening.

A 58-year-old woman with breast cancer with multiple prior courses of systemic treatments presented with hypotension, hypoxia, significant polyuria, and polydipsia. Mild thickening of the pituitary stalk was seen, while no discrete sellar or suprasellar masses were noted. What is your diagnosis?

This essay explores how cancer is depicted in the work of Georgia O’Keeffe and Hannah Wilke.

This essay discusses the authors’ experience with and lessons learned from their hospital’s telemedicine-based service for managing low-risk acute lymphoblastic leukemia in children who have achieved complete remission.

The past decade has seen many advances in the treatment of haematological malignancies, particularly with the rise of immunotherapies and CAR T-cell therapies. Other treatments, such as tyrosine kinase inhibitors for chronic myeloid leukaemia, have changed the disease to that of a chronic condition, treated with continuously administered therapies that have unique adverse events over time. With these changes, how adverse events are measured, reported, and the patient's perception of these adverse effects needs to be updated as well.

In modern haematology, toxicities often persist long after completion of treatment regimens. Advances in overall survival, alongside the expanded adoption of continuous dosing regimens, immunotherapies, and cellular therapies, have rendered adverse events a lasting burden for patients throughout remission, chronic disease management, and long-term survivorship. Yet the standard Common Terminology Criteria for Adverse Events (CTCAE) maximum grade only records toxicity at its worst point, rather than its persistence, recurrence, cumulative burden, or short-term or long-term effects on daily life.

We thank Ankur Jain for their thoughtful comments regarding our FAIR trial1 and the discussion regarding the prevention of anaemia during pregnancy.2 Our findings show that, among women with non-anaemic iron deficiency diagnosed at the first antenatal care visit, intravenous iron was superior to 30 mg daily oral iron in preventing maternal anaemia. We take the opportunity to address the points raised in the Correspondence.

Dr Steven McKenzie (Cardeza Foundation for Hematologic Research, Philadelphia, PA, USA) and colleagues presented the ALATHEA trial (NCT05785819) that compared the safety and efficacy of 200 mg intravenous VLX-1005 every 12 h (a small-molecule inhibitor of 12-lipoxygenase) versus placebo in patients with suspected heparin-induced thrombocytopenia undergoing standard-of-care treatment with a direct thrombin inhibitor. 24 patients were randomised 1:1 to the two treatment groups; 22 received study treatment and 17 had confirmed HIT (eight received VLX-1005 and nine placebo).

On June 12, 2026, WHO released its latest global report on blood safety and availability, drawing on data from 168 countries. Voluntary unpaid donors now account for 85% of blood donations. Total blood collections increased by 19% from 2013 to 2023 across 132 countries. Nonetheless, governance and oversight remain patchy. 48 countries do not have specific legislation addressing the safety and quality of blood and blood products for transfusion, while 62 countries have not established systems for regular inspection of blood transfusion services.

Nepal, a landlocked country in south Asia bordered by China and India, is known for its geographical, cultural, and religious diversity. It is the only country with a living goddess—The Kumari—a chosen pre-menarcheal girl from Newar community worshipped by all Nepalis, including the head of state. But among this diversity is the belief around menstruation (although differing between region, cast, and culture) that leads to nearly 89% of Hindu women and girls in Nepal to experience some form of menstrual restriction.

When politics and reproductive health intersect, women, girls, and people with the potential to menstruate can be substantially impacted, as seen recently in the USA. The devastating effects of undermining and defunding women's health programmes have generated worthy media attention; however, progress in reproductive health is less fêted. As an example, Ireland has emerged as a progressive voice for women's health despite the persistence into the 21st century of highly restrictive, conservative legislation shaped by historical religious influences on society.

I was remembering all the times I wanted to talk to my dad to ask him about what was happening to me, but he avoided it every time. He did not want to accept that I also needed special medical care. It hurt me a lot to see my dad suffering because of haemophilia, but it hurt me even more not to feel accepted or seen by him.

Epcoritamab plus rituximab–lenalidomide showed high activity in first-line treatment for follicular lymphoma, with 95% of patients having a response over 3 years of follow-up, supporting this treatment regimen as a promising approach that warrants further analysis to ascertain its role in this setting.

The addition of venetoclax to DA-EPOCH-R resulted in excess mortality, prompting early study closure. Robust accrual shows that prospective multicentre trials are feasible in double-hit lymphoma, and the outcomes in the DA-EPOCH-R group serve as a benchmark for future studies.

We showed that allo-HSCT is an effective and potentially curative treatment option for patients with hepatosplenic T-cell lymphoma; auto-HSCT is frequently followed by relapse and might be only recommended to patients with a complete response and ineligible for allo-HSCT.

The results of this study showed the feasibility of rapid multicentre decentralised manufacturing and delivery of fresh CAR T-cell therapy in heavily pretreated B-cell non-Hodgkin lymphoma. The phase 2 part of ATALANTA-1 will provide further information on clinical activity and safety.

With more potent and novel treatment options, the number of survivors of haematological malignancies is increasing steadily, which in turn leads to the need for parallel improvements in survivorship monitoring and care. The present paper forms part of The Lancet Haematology Series on adverse event reporting, dedicated to improving adverse event assessment in haematological malignancies. Here, we review current survivorship care practice from a global perspective and conclude that access to long-term care plans is highly heterogeneous, with insufficient adaptation to the specific needs of haematological malignancy survivors treated curatively or non-curatively.

The therapeutic landscape of haematological malignancies has evolved rapidly with the introduction of targeted therapies, immunotherapies, and cell-based and gene-based interventions, leading to improved survival and, in some cases, long-term remission or cure. These advances have exposed limitations in traditional approaches to adverse event assessment and reporting. Building on the 2025 Lancet Haematology Series on adverse event reporting, this Series paper examines how proposed improvements in toxicity reporting can be operationalised and integrated into regulatory decision making across clinical trials and real-world settings.

Real-world data are essential for understanding treatment-related toxicities in haematology, but traditional analyses are limited by data access, sharing constraints, and reduced data granularity. Emerging digital health technologies (DHTs), such as electronic patient-reported outcomes and wearable devices, can be used to capture continuous, patient-generated data not reliably captured by current post-marketing toxicity assessments. Artificial intelligence, synthetic data, and digital twins can be used to predict and simulate toxicity at a much larger scale beyond the capacity of traditional methodologies.

A 34-year-old man was admitted to Ruijin Hospital (Shanghai, China) in December, 2024, with acute onset of unexplained high fever and a 1-year history of mild splenomegaly. Laboratory testing showed rapidly progressive leukocytosis with 36% circulating blasts and thrombocytopenia. Abdominal ultrasonography verified splenomegaly, with the spleen measuring 156 mm in length and 58 mm in thickness.

Connexins are membrane channel–forming proteins in hematopoietic stem cells and the bone marrow niche that coordinate intercellular communication, metabolism, and regeneration during hematopoietic stress. In this review, Singh, Rallis, and Cancelas highlight the emerging role of connexin-43 in coordinating stem cell function, mitochondrial dynamics, and niche remodeling. They also explore its therapeutic potential in enhancing hematopoietic recovery and targeting malignant microenvironments.

The final analysis of the ANDROMEDA trial presented by Kastritis and colleagues shows that adding daratumumab to cyclophosphamide, bortezomib, and dexamethasone improves hematologic responses and overall survival in newly diagnosed AL amyloidosis. The study establishes cardiac complete response as a key prognostic end point and supports the development of more effective, less toxic frontline therapies.

Early treatment with ibrutinib improves event-free but not overall survival in asymptomatic early-stage chronic lymphocytic leukemia (CLL), reinforcing a watch-and-wait approach as the standard of care. Riecke and colleagues show that even high-risk genetic subgroups, including patients with TP53 mutations, do not gain survival benefit from early intervention. These findings highlight that, while genomic profiling is necessary for prognostication and treatment selection, adverse genetic risk alone should not prompt therapy initiation for asymptomatic CLL.

T-cell exhaustion limits the efficacy of T-cell–redirecting therapies. Using complementary approaches, these companion manuscripts by Chiu and colleagues and by Chen and colleagues show that mezigdomide, which degrades IKZF1 and IKZF3 (the transcription factors Ikaros and Aiolos), enhances T-cell fitness by preventing and potentially reversing exhaustion, thereby improving bispecific antibody and chimeric antigen receptor T-cell activity. These findings support combining potent IKZF1/3 degraders with T-cell–redirecting therapies to enhance responses in multiple myeloma and other malignancies.

T-cell exhaustion limits the efficacy of T-cell–redirecting therapies. Using complementary approaches, these companion manuscripts by Chiu and colleagues and by Chen and colleagues show that mezigdomide, which degrades IKZF1 and IKZF3 (the transcription factors Ikaros and Aiolos), enhances T-cell fitness by preventing and potentially reversing exhaustion, thereby improving bispecific antibody and chimeric antigen receptor T-cell activity. These findings support combining potent IKZF1/3 degraders with T-cell–redirecting therapies to enhance responses in multiple myeloma and other malignancies.

Spliceosome mutations are the most common genetic alterations in myelodysplastic syndromes (MDS), but shared pathogenic splicing events that drive disease development remain incompletely defined. Chen and colleagues identify the alternatively spliced isoform of methyl-binding domain 1 (MBD1-L) as a recurrent RNA-driven abnormality that impairs erythroid differentiation and hematopoietic function in MDS. Targeting MBD1-L splicing with antisense oligonucleotides restores erythroid maturation, revealing a potential therapeutic strategy for RNA-driven epigenetic dysregulation.

Aneuploidy is a hallmark of cancer genomes, yet its evolution and functional consequences are poorly understood. Creamer and colleagues used an induced pluripotent stem cell–based acute myeloid leukemia (AML) model and single-cell profiling to show that TP53 mutations and chromosome 5q deletion cooperate to drive complex karyotype evolution. Despite diverse chromosomal alterations, aneuploid clones converge on a shared progenitorlike transcriptional program that confers sensitivity to the BCL2 inhibitor venetoclax. These findings reveal how genomic evolution shapes therapeutic vulnerabilities and provide a framework for targeting complex-karyotype AML.

Heparin-induced thrombocytopenia (HIT) is an immune disorder with potentially catastrophic thrombotic consequences. Yu et al identified the histone demethylase Jumonji domain–containing 1C (Jmjd1c) as an epigenetic regulator of B-cell tolerance that suppresses pathogenic anti–platelet factor-4/heparin antibody production. Using a B-cell–specific Jmjd1c knockout model, they show that Jmjd1c loss promotes B-cell activation, increased H3K36me1 methylation, and generation of platelet-activating antibodies. These findings reveal an epigenetic checkpoint regulating HIT susceptibility and autoimmune thromboinflammation.

Fibroblast growth factor 23 (FGF23), a bone-derived regulator of mineral metabolism, also influences erythropoiesis. Courbon and colleagues show that iron deficiency induces erythroid FGF23 production, with full-length FGF23 suppressing red blood cell maturation through FGF receptor 1 signaling. In chronic kidney disease, impaired FGF23 cleavage promotes excess active FGF23, worsening anemia and linking mineral metabolism with iron homeostasis and erythropoiesis.

Thromboinflammation, which links platelet activation and immune responses, drives cardiovascular injury and thrombo-occlusive disease. Lin and colleagues identified interleukin 4 (IL-4) as an inhibitory ligand for the platelet collagen receptor glycoprotein VI (GPVI) that suppresses platelet activation, thrombus formation, and leukocyte recruitment. These findings highlight IL-4–GPVI signaling as a potential therapeutic target for thromboinflammatory disorders while preserving hemostasis.

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Using a blood test to track thymidine kinase activity may help determine optimal first-line treatment for patients with BRAF V600–mutated metastatic melanoma, according to findings published in Clinical Cancer Research. 

Adding high-dose vitamin D3 to standard chemotherapy plus bevacizumab did not improve progression-free survival (PFS) in patients with previously untreated metastatic colorectal cancer (mCRC), according to results from the phase III SOLARIS trial led by Kimmie Ng, MD, MPH, and colleagues and...

An additional safety analysis of the global phase III DESTINY-Breast05 trial evaluating the HER2-directed antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) has further established the pulmonary safety profile of T-DXd with radiotherapy, according to Michael Untch, MD, PhD, of Helios...

Today, the U.S. Food and Drug Administration (FDA) approved ropeginterferon alfa-2b-njft (Besremi) for the treatment of adults with essential thrombocythemia, making it the first new FDA-approved treatment for essential thrombocythemia in nearly 3 decades. Ropeginterferon alfa-2b-njft has been...

On August 28, the U.S. Food and Drug Administration (FDA) approved rusfertide (Mimrylo) for the treatment of erythrocytosis in adults with polycythemia vera (PV). Rusfertide is a first-in-class hepcidin mimetic designed to regulate iron distribution in the body and red blood cell overproduction to...

According to findings from the prospective multicenter LAANTERN study reported by Leuthardt et al in the Journal of Clinical Oncology, laser interstitial thermal therapy (LITT) may offer a minimally invasive cytoreductive option for selected patients with primary and metastatic brain tumors, with...

A tissue-free circulating tumor DNA (ctDNA) assay was strongly prognostic for recurrence in patients treated for triple-negative breast cancer and provided a lead time to recurrence comparable to that of a multivariant tumor-informed assay, according to findings from a prognostic study published by ...

Researchers have reported that a chemotherapy-free combination of four targeted therapies showed encouraging results in patients with hormone receptor (HR)-positive, HER2-positive metastatic breast cancer, offering a potential first-line treatment option that may be more convenient for some...

A comparative study of the cancer clinical trial portfolios supported by federal funding vs industry funding reveals they have distinct, interdependent roles in cancer research. The findings were published by Unger et al in JAMA Oncology.

A blood-based assay combining cell-free DNA (cfDNA) fragmentomics with droplet digital PCR–based methylation analysis improved detection of early-stage colorectal cancer (CRC) and precancerous lesions, according to findings presented at the 2026 ASCO Breakthrough meeting in Singapore.

AI is one of the most transformative technological advancements of our time, poised to revolutionize every aspect of our lives, including health care. On August 28, 2026, Cleveland Clinic in collaboration with the College of Healthcare Information Management Executives (CHIME), will host the Second ...

Artificial intelligence (AI) is one of the most transformative technological advancements of our time, poised to revolutionize every aspect of our lives, including health care.

An updated clinical guideline from the American Society for Radiation Oncology (ASTRO) provides evidence-based recommendations on the use of radiation therapy to treat adult patients with pancreatic cancer. The guideline updates ASTRO’s 2019 recommendations to reflect recent clinical trials that...

Andrés M. Bur, MD, FACS, has been named Chief of the Division of Head and Neck Surgery in the Department of Otolaryngology–Head & Neck Surgery at WashU Medicine and Co-Director of the Robert Ebert and Greg Stubblefield Head and Neck Tumor Center at Siteman Cancer Center, based at Barnes-Jewish...

Colorectal cancer may result in tumor-related inflammation that damages peripheral nerves before even starting cancer treatment, according to preclinical findings published in Nature Communications. This damage may be the reason why colorectal cancer survivors are more likely to develop peripheral...

Patients with acute myeloid leukemia (AML) frequently experienced unplanned hospital readmission or death within 30 days after discharge following induction chemotherapy, according to findings reported by Chae et al in JCO Clinical Cancer Informatics. The investigators found that incorporating...

In the international phase III NRG-GU005 trial, stereotactic body radiotherapy (SBRT) improved bowel-related quality of life vs moderately hypofractionated intensity-modulated radiotherapy (IMRT) in patients with favorable intermediate-risk prostate cancer. However, Ellis et al reported in JAMA...

On August 25, 2026, the U.S. Food and Drug Administration (FDA) approved zanidatamab-hrii (Ziihera) for two indications, including:

On August 26, the U.S. Food and Drug Administration (FDA) approved daraxonrasib (Rasonque), an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.

The human immune system has specialized cells called CD4 cytotoxic T lymphocytes (CD4 CTLs), which have been shown to kill tumor cells in some cancers. These cells multiply in a process called clonal expansion to help fight infection. In a study published by Hashimoto in Cell Reports, researchers...

Metabolic abnormalities were frequently documented during the first year after men with prostate cancer began concurrent androgen-deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI), according to a large retrospective cohort study led by Amy L. Shaver, PhD, PharmD, MPH, and...

Adults who have survived Hodgkin lymphoma for at least 5 years may face significantly elevated long-term health risks and cancer and noncancer mortality, according to a new study led by researchers at The University of Texas MD Anderson Cancer Center. The retrospective population-based study,...

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.

Belzutifan plus lenvatinib delays disease progression in advanced-stage RCC

The global cancer burden is projected to rise substantially in the coming decades, driven largely by population growth and ageing. Yet cancer patterns and outcomes vary widely across regions, reflecting differences in exposures, healthcare capacity and access to care. Translating these evolving epidemiological patterns into effective and equitable cancer-control strategies is increasingly urgent.

Despite considerable progress in other cancer types, progress with the development of targeted therapies for patients with glioblastoma has remained limited, despite considerable research effort. In this Review, the authors summarize the various attempts to develop effective targeted therapies for patients with glioblastoma, including some of the challenges that have likely impaired progress thus far. The authors also highlight novel therapies, clinical trial designs and research directions that have been informed by the shortcomings of previous research efforts, all of which might eventually lead to improved outcomes for patients.

The phase III FIGHT-302 trial demonstrated that the FGFR inhibitor pemigatinib improves progression-free survival and response rates versus first-line chemotherapy in patients with advanced-stage FGFR2-rearranged cholangiocarcinoma. However, the trial accrued slowly and closed early after chemoimmunotherapy became the new standard of care. FIGHT-302, alongside two similarly terminated trials, highlights the need for innovative trial designs and flexible regulatory frameworks to evaluate therapies in rare, biomarker-defined populations.

PROTEUS met its amended co-primary end points but should not be interpreted as practice changing. The trial compared two experimental strategies rather than the current standard of care, relied on an unvalidated approach (prostate-specific membrane antigen-PET) for assessments of metastasis-free survival, demonstrated minimal absolute benefit with increased toxicity and lacks both mature overall survival data and sufficient data on patient-reported outcomes to support adoption.

Yue and colleagues present a landmark anatomical atlas of human protein abundance across non-malignant tissues and cancers. We argue that precision oncology needs functional proteomic maps that add signalling activity, post-translational modifications, pathology-guided compartment resolution, metastatic and longitudinal sampling, clinical annotation and population diversity to make proteomics therapeutically actionable.

HCT–ASCT confirmed as standard-of-care consolidation therapy for PCNSL

Oncology clinical trials are characterized by high failure rates — reflecting both the biological complexity of cancer and operational inefficiencies — and the generalizability of their results is often limited. In this Review, the authors discuss opportunities to address these limitations via application of artificial intelligence tools across the lifecycle of clinical trials as well as key challenges that must be overcome for routine clinical deployment of these tools.

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GSK’s vaccine—which targets two primary flu antigens—elicited higher immune responses in both younger and older adults in a mid-stage study. The Phase 3 launch, planned for September, follows the FDA’s recent approval for Moderna’s mRNA flu vaccine.

Shares of Germany-based BioNTech were down as much as 8% Friday after announcing a Phase 2 trial of autogene cevumeran would be discontinued for futility. The news follows Merck and Moderna’s Phase 3 win last week for their cancer vaccine plus Keytruda in melanoma.

While Bausch + Lomb’s dual-action eye drops failed to outperform active comparators at day 29, the investigational asset showed significant superiority at day 15.

A surprise flop in Phase 2a cystic fibrosis trial sent Sionna’s shares plummeting, but for Vertex, the news reinforced its standard-of-care standing with highly successful drugs like Trikafta.

The Phase 2 study was small and was not designed to establish the statistical difference between Vistagen’s drug candidate and placebo, according to Vistagen. The biotech plans to meet with the FDA to determine a registrational path for the asset.

BioVie’s stock fell by nearly 50% as the biotech claimed victory in a mid-stage Parkinson’s disease trial using an alternative endpoint to the primary clinical goal.

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

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

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

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

GSK’s vaccine—which targets two primary flu antigens—elicited higher immune responses in both younger and older adults in a mid-stage study. The Phase 3 launch, planned for September, follows the FDA’s recent approval for Moderna’s mRNA flu vaccine.

Safety and dosing are likely to be “key differentiators” for Arrowhead Pharmaceuticals as it looks to challenge Ionis Pharmaceuticals’ lead in the severe hypertriglyceridemia market.

AstraZeneca and Ionis Pharmaceuticals’ data drop divulging more details from its highly watched Phase 3 transthyretin silencer trial “further confuses the picture” for Wainua when combined with the standard of care for ATTR-CM, analysts say.

AstraZeneca and Amgen co-develop and co-commercialize Tezspire under an April 2012 agreement. The partners are now planning another FDA submission for the asthma drug, which received an expansion into chronic rhinosinusitis last year.

The Phase 3 readout is the first for ivonescimab beyond non-small cell lung cancer to show a significant overall survival benefit, according to Summit Therapeutics and China-based partner Akeso.

The Phase 3 study is evaluating two doses of Novo’s Wegovy pill in people with obesity or overweight in combination with a reduced-calorie diet and increased physical activity.

Melanoma was slower to recur in patients receiving Merck and Moderna’s mRNA vaccine with Keytruda, supporting use of the combination in adjuvant treatment. The partners plan to take the data to the FDA.

With a Phase 3 trial showing a reduction of serious and severe hypoglycemic episodes in patients who have undergone weight loss surgery, Amylyx Pharmaceuticals plans to file for approval this year. If granted market entry, avexitide could hit peak sales of $1.7 billion worldwide, analysts estimate.

EyePoint’s quest to reduce treatment burden for patients with age-related macular degeneration has hit a bump in the road, with a clinical miss driving the biotech’s stock down by 70%.

AstraZeneca will push through with its other Phase 3 studies for volrustomig, including in cervical cancer and mesothelioma.

GSK’s vaccine—which targets two primary flu antigens—elicited higher immune responses in both younger and older adults in a mid-stage study. The Phase 3 launch, planned for September, follows the FDA’s recent approval for Moderna’s mRNA flu vaccine.

Safety and dosing are likely to be “key differentiators” for Arrowhead Pharmaceuticals as it looks to challenge Ionis Pharmaceuticals’ lead in the severe hypertriglyceridemia market.

Shares of Germany-based BioNTech were down as much as 8% Friday after announcing a Phase 2 trial of autogene cevumeran would be discontinued for futility. The news follows Merck and Moderna’s Phase 3 win last week for their cancer vaccine plus Keytruda in melanoma.

AstraZeneca and Ionis Pharmaceuticals’ data drop divulging more details from its highly watched Phase 3 transthyretin silencer trial “further confuses the picture” for Wainua when combined with the standard of care for ATTR-CM, analysts say.

Manufacturers are being pushed beyond mAb‑era platforms into a new design model built around molecular engineering, complex analytics and amplified upstream and downstream processing.

Phase 1 data from Generate Biomedicines’ ongoing chronic obstructive pulmonary disease study demonstrated “rapid and sustained reductions” across four disease biomarkers.

AstraZeneca and Amgen co-develop and co-commercialize Tezspire under an April 2012 agreement. The partners are now planning another FDA submission for the asthma drug, which received an expansion into chronic rhinosinusitis last year.

In this episode of Denatured, you’ll hear from Hilary Rosselot, executive director at the National Fragile X Foundation and Jordi Fàbrega, co-founder & CEO at CONNECTA Therapeutics. From trial endpoints and placebo effects to neuroplasticity modulation, we explore what it will take to build a sustainable path to the first approved therapy.

The Phase 3 readout is the first for ivonescimab beyond non-small cell lung cancer to show a significant overall survival benefit, according to Summit Therapeutics and China-based partner Akeso.

The talent pool not keeping pace with increased outsourcing demand is just one reason CDMOs have trouble filling roles, according to a search expert. He also told BioSpace who is most in demand and how candidates can stand out from the competition.

On August 26, 2026, the Food and Drug Administration approved daraxonrasib (RASONQUE, Revolution Medicines, Inc.), an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.

On August 13, 2026, the Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus, Bristol-Myers Squibb Company) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.

On August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.

On July 31, 2026, the Food and Drug Administration approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or-sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer).

On July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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