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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.

Among patients with relapsed small-cell lung cancer after chemotherapy, treatment with tambotatug pelitecan led to longer survival than treatment with topotecan, with fewer adverse events of grade 3 or higher.

The authors report the results of interim analyses of two phase 3 studies of exa-cel, a gene-edited cellular therapy, in children with transfusion-dependent β-thalassemia or sickle cell disease.

Severe acquired methemoglobinemia was identified in 82 migrants disembarking in Sicily, 74 of whom were treated with methylene blue. Dermal absorption of N-methylaniline was identified as the likely cause.

The authors summarize treatment for multiple myeloma, highlighting four-drug induction therapy, evolving transplantation strategies, tailored maintenance therapy, and in relapse, earlier use of BCMA-directed immunotherapy.

Sickle cell disease and β-thalassemia are highly prevalent inherited conditions associated with serious complications and a shortened life span. Transfusions in patients with severe β-thalassemia and hydroxyurea therapy in those with sickle cell disease can improve outcomes for many of these patients, yet early diagnosis, consistent access to safe blood...

A dying patient in a state psychiatric hospital has no access to a DNR order that would make the process as peaceful as possible — as the notorious Bedlam casts a shadow over mental health care to this day.

A 3-year-old boy with chemotherapy-resistant metastatic hepatoblastoma had complete regression lasting at least 12 months after two infusions of glypican-3–specific CAR T cells coexpressing interleukin-15 and interleukin-21.

Kunihiro Hattori, Tomoyuki Igawa, and Takehisa Kitazawa, who developed a prophylactic therapy for hemophilia A, have received the 2026 Lasker–DeBakey Clinical Medical Research Award.

In a phase 1–2 study of daraxonrasib, 54% of patients with RAS-mutant non–small-cell lung cancer had grade 3 or higher adverse events, mainly pneumonia, diarrhea, and rash; more than 30% of patients had a response.

In a randomized phase 2 trial involving adults with AML, azacitidine–venetoclax led to longer event-free survival than induction chemotherapy, with a lower risk of severe infection and hemorrhage.

This review summarizes the management of pulmonary nodules, with an emphasis on nodule type, imaging follow-up, cancer risk, and strategies to balance timely diagnosis with avoidance of unnecessary procedures.

I first treated a patient with leukemia with the so-called “7+3” regimen (a 7-day continuous infusion of cytarabine plus three daily infusions of an anthracycline, usually daunorubicin)1 more than 50 years ago during my residency. To be candid, I had little understanding of what I was doing but...

Among 16 patients with refractory neurologic autoimmune disorders, lentiviral CD19 CAR T-cell therapy was associated with manageable side effects, complete B-cell depletion, and preliminary clinical improvement across disease groups.

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.

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.

Many male survivors do not perceive heightened risks for SD, despite a history of treatment‐related risk factors. Because SD risk is multifactorial, oncology and survivorship providers should prioritize individualized education and counseling to improve survivors’ understanding of their risk on the basis of their treatment history and current health.

Addressing barriers for individuals with self‐care limitations could improve suboptimal screening levels across multiple cancer screenings. Self‐sampling modalities, including stool testing, may mitigate accessibility issues, and warrant further evaluation.

The early period after cancer diagnosis represents a critical window of increased IS risk. Incorporating targeted cerebrovascular risk assessment into oncologic care may facilitate earlier identification of high‐risk subgroups and support tailored prevention strategies.

In patients with surgically treated thymic malignancies, tumor invasiveness, especially vascular invasion, was the strongest predictor of recurrence and should guide risk stratification. Failure was predominantly pleural, with rare in‐field recurrence, indicating good local control but a need for better strategies against pleural relapse. Survival benefit from peri‐operative radiation remains uncertain and should be tested prospectively.

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.

Graft-versus-host disease (GVHD) remains a major challenge after allogeneic bone marrow transplantation. Negrin and Meyer review the pathobiology of GVHD, the biology of regulatory immune cells, and the preclinical studies that led to clinical testing of CD4⁺CD25⁺FOXP3⁺ regulatory T cells in allogeneic hematopoietic cell transplantation, culminating in a recent US Food and Drug Administration approval.

Chimeric antigen receptor (CAR) T-cell therapy has transformed the treatment of large B-cell lymphoma (LBCL), but long-term follow-up is essential. Abramson et al report 5-year results for relapsed/refractory (R/R) LBCL from TRANSCEND NHL-001, showing durable outcomes with a 5-year overall survival of 38%, comparable to other approved CAR-T products. Although long-term follow-up excluded more than one-third of eligible survivors, these data provide important evidence of CAR-T durability and will help inform treatment decisions in an era of multiple CAR-T and bispecific antibody options.

Transition of hematopoietic stem cells (HSCs) from quiescence to lineage commitment requires precise posttranscriptional control, but the role of mRNA isoform regulation is incompletely defined. Liudkovska et al show that translational control of splicing factor 1 (Sf1) coordinates alternative splicing during hematopoietic differentiation, linking Sf1-dependent splicing programs to translation and DNA damage response pathways in hematopoietic stem and progenitor cells. This study underscores the importance of posttranscriptional regulatory mechanisms in the regulation of HSC cell fate.

Although idecabtagene vicleucel (ide-cel) induces deep responses in relapsed/refractory multiple myeloma, most patients relapse within 1 year. Using single-cell sequencing, Noble et al identified an infusion product transcriptional signature, marked by NF-κB, prosurvival, chemokine/tonic signaling, and higher chimeric antigen receptor (CAR) expression, that is enriched in CAR⁺ CD4⁺ T cells and independently associated with improved progression-free and overall survival. These findings suggest that product-intrinsic transcriptional fitness may better predict durable CAR-T activity than current potency assays.

T-cell acute lymphoblastic leukemia (T-ALL) has a high relapse rate and remains difficult to treat, with few recurrent kinase drivers identified and no approved targeted therapies. Using a multiomics approach, Montanaro et al identified the atypical serine/threonine kinase WNK1 (with no lysine 1) as a dependency in TAL-rearranged T-ALL and show that its inhibition induces mitotic defects. This work supports WNK1 as a promising therapeutic target for this poor-prognosis subgroup.

Primary myelofibrosis is characterized by dysplastic megakaryocytes with an impaired demarcation membrane system (DMS) and defective proplatelet formation. Chiu et al show that deficiency of Fas-associated phosphatase 1 (FAP-1) disrupts DMS formation, impairing megakaryocyte maturation and platelet function and, with aging, promoting myelofibrosis-like features. Their findings identify FAP-1 as a previously unrecognized regulator of megakaryocyte maturation and provide new insight into how megakaryocyte dysfunction may contribute to the pathogenesis of myelofibrosis.

Although interferon alfa (IFN-α) is an effective treatment for polycythemia vera (PV), its immune-mediated mechanisms remain unclear. Lossa et al show that IFN-α expands CD27⁺ natural killer (NK) cells in a transgenic mouse model of PV and increases CD56^bright NK cells in patients with PV, correlating with molecular response. NK cells, via subsequent tumor necrosis factor α secretion, selectively eliminate JAK2-mutant clones, providing an immune mechanism for the therapeutic effects of IFN-α in PV.

Adults with sickle cell disease (SCD) remain at risk for white matter injury and cognitive decline despite modern therapy. Wang et al show that blood-brain barrier (BBB) disruption is common in adults with SCD and is associated with brain microstructural injury. Proteomic analyses link increased BBB permeability to pathways involving immune regulation, extracellular matrix degradation, lipid metabolism, and arginine-proline metabolism, suggesting potential therapeutic avenues.

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.

Publisher Correction: Beyond cold to hot: oncolytic virotherapy as the next cornerstone of immuno-oncology

Liver resection improves survival in patients with locally advanced HCC

The development of diverse immunotherapeutic modalities has revolutionized the treatment of cancer but the effectiveness of these therapies remains restricted by fundamental mechanistic limitations relating to the generation of tumour-specific T cells, and their activation and/or access into the tumour microenvironment. In this Perspective, the authors position oncolytic viruses as a foundational immuno-oncology platform for systemic immune reprogramming to simultaneously overcome these availability, activation and admission barriers, and delineate four pillars for the development of a new generation of oncolytic virotherapies.

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.

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The polycythemia vera field is heating up, with Disc Medicine and Silence Therapeutics each advancing next-generation therapies, playing catch-up to Takeda and Protagonist Therapeutics, who won the FDA’s approval last month for Mimrylo.

The enrollment pause comes after BHV-7000 failed to show efficacy in a midstage depression trial late last year. The news is another regulatory hit for Biohaven after the FDA declined to approve its spinocerebellar ataxia treatment in November 2025.

Despite falling short of analyst expectations, Tyra Biosciences is taking its cancer drug to registrational development for non-muscle invasive bladder cancer.

Bristol Myers Squibb is positioning arlo-cel for quadruple-class exposed patients, which could help reduce competition with an upcoming multiple myeloma CAR T therapy from Gilead Sciences, according to BMO Capital Markets.

Inhibrx CEO Mark Lappe was particularly keen on INBRX-106’s performance in patients with HPV-positive disease and sees a nearly $4 billion near-term opportunity thanks to the Phase 2 results.

Structure Therapeutics’ oral GLP-1 candidate aleniglipron showed 72-week efficacy “in line” with Novo Nordisk’s oral Wegovy, BMO Capital Markets wrote in a note to investors. Meanwhile, Structure’s amylin and calcitonin receptor agonist ACCG-2671 showed “impressive” target engagement in a Phase 1 trial of healthy volunteers, according to Leerink Partners.

Mosliciguat, being developed by the Roivant Sciences subsidiary Pulmovant, ‘significantly exceeded expectations’ in reducing pulmonary vascular resistance, according to analysts, and is progressing to a late-stage study.

The data, which come from a subgroup in an earlier trial that Truist Securities called “the most relevant” to Revolution Medicines’ ongoing Phase 3 test in RAS mutant NSCLC, showed a 42% overall response rate and overall survival of 16 months.

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.

Positive topline results from a second straight study in generalized anxiety disorder shift the narrative for Definium Therapeutics’ DT120 to commercialization, Jefferies analysts said Monday, while Stifel wrote that the asset is moving towards an FDA submission.

SERENA-4 was assessing AstraZeneca’s Etcamah as a first-line option for certain patients with advanced breast cancer—a setting that could have meant a $2.9 billion opportunity for the drug.

Novartis’ shares fell 13% this week after the report of three separate late-stage asset setbacks. The impact went beyond the Swiss drugmaker, dragging peers down across the market.

Back-to-back failures of multiple late-phase trials have raised questions about how Novartis has deployed capital in pursuit of drugs to drive growth through the 2030s.

The enrollment pause comes after BHV-7000 failed to show efficacy in a midstage depression trial late last year. The news is another regulatory hit for Biohaven after the FDA declined to approve its spinocerebellar ataxia treatment in November 2025.

After the failure of Novo Nordisk’s IL-6 inhibitor ziltivekimab sent waves through the industry, the company has terminated two other studies of the asset, bringing the total number of high-profile cardiovascular flops to six over nine weeks.

While Novartis’ antibody-oligonucleotide conjugate failed to significantly improve hand function in patients with myotonic dystrophy type 1, the asset nevertheless showed signs of clinical activity in secondary and exploratory measures.

The failure of Novartis’ pelacarsen to translate its Lp(a)-lowering effects to clinical benefits “marks a meaningful setback” for other companies taking a similar approach to cardiovascular risk, analysts say—including Eli Lilly and Amgen.

AbbVie’s etentamig has a relatively cleaner safety profile and an administration schedule that could give it an edge over other BCMA-targeting multiple myeloma therapies on the market, according to BMO Capital Markets.

New Phase 3 data show that Summit Therapeutics and Akeso’s PD-1/VEGF therapy improved overall survival in patients with a type of lung cancer as compared to Merck’s Keytruda but the results will need to be replicated in non-Chinese patients.

BioNTech, Summit Therapeutics, GSK and Roche have made a splash at the ongoing World Conference on Lung Cancer taking place in South Korea. These companies and their partners have all shared new findings for their closely watched programs, highlighting overall survival benefits in various types of lung cancer.

Positive topline results from a second straight study in generalized anxiety disorder shift the narrative for Definium Therapeutics’ DT120 to commercialization, Jefferies analysts said Monday, while Stifel wrote that the asset is moving towards an FDA submission.

SERENA-4 was assessing AstraZeneca’s Etcamah as a first-line option for certain patients with advanced breast cancer—a setting that could have meant a $2.9 billion opportunity for the drug.

The polycythemia vera field is heating up, with Disc Medicine and Silence Therapeutics each advancing next-generation therapies, playing catch-up to Takeda and Protagonist Therapeutics, who won the FDA’s approval last month for Mimrylo.

Novartis’ shares fell 13% this week after the report of three separate late-stage asset setbacks. The impact went beyond the Swiss drugmaker, dragging peers down across the market.

Back-to-back failures of multiple late-phase trials have raised questions about how Novartis has deployed capital in pursuit of drugs to drive growth through the 2030s.

The enrollment pause comes after BHV-7000 failed to show efficacy in a midstage depression trial late last year. The news is another regulatory hit for Biohaven after the FDA declined to approve its spinocerebellar ataxia treatment in November 2025.

Despite falling short of analyst expectations, Tyra Biosciences is taking its cancer drug to registrational development for non-muscle invasive bladder cancer.

In this episode of Denatured, sponsored by SK pharmteco, Jennifer Smith-Parker speaks to Arvind Singh, vice president and global head of supply chain. In this episode, we explore how CDMOs are reshaping supply‑chain strategy for a new generation of complex modalities.

September has been a rough month already for Novo Nordisk, which canned two more late-stage trials of its embattled IL-6 inhibitor, and Novartis, which took Phase 3 hits in both cardiovascular and muscular dystrophy indications; Ultragenyx’s big bet in Angelman syndrome failed to yield benefit in Phase 3 but Ionis’ Pharmaceuticals nabbed the first targeted approval for Alexander disease; and on the business side, biopharma investment is back in a big way.

On September 9, 2026, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.

On September 4, 2026, the Food and Drug Administration granted accelerated approval to camizestrant (Etcamah, AstraZeneca), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test. 

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.

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