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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.

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

For decades, pancreatic ductal adenocarcinoma (PDAC) has been perhaps the clearest example of a cancer that is driven by a dominant oncogenic event yet is resistant to therapeutic exploitation. More than 90% of pancreatic cancers harbor activating RAS mutations, most commonly those involving KRAS codon 12,...

For more than two decades, neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy has been the standard of care for muscle-invasive bladder cancer. Despite this approach, relapse rates have remained high and long-term survival gains have been modest. The treatment landscape began to shift with the NIAGARA trial, which showed a...

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

Aug 9 marks the UN's International Day of the World's Indigenous Peoples. Although Indigenous Peoples represent just 6% of the global population, they make up more than 15% of individuals living in extreme poverty worldwide. Indigenous Peoples have a holistic view of health, comprising spiritual, environmental, cultural, and social dimensions. However, poor understanding and incorporation of these concepts into Western medicine, alongside institutional bias and the legacy of colonisation, have led to persistent health disparities between Indigenous Peoples and non-Indigenous counterparts across a spectrum of diseases and cancer is a prime example.

In contemporary management of patients with hormone receptor-positive, HER2-negative metastatic breast cancer, it is standard to switch therapies at tumour progression, defined by RECIST criteria in clinical trials, and by other measures (many, ironically, considered non-measurable by RECIST) in clinical practice, including subtler radiological changes, findings on examination, rising tumour markers, or increased symptoms related to cancer.1 Accordingly, in the clinic, a treatment change can be considered for symptomatic progression despite radiologically stable disease, or the same treatment might be continued beyond asymptomatic oligoprogression.

The recently reported SUPREMO trial evaluated chest wall radiotherapy after mastectomy in patients with intermediate-risk breast cancer. Although chest wall radiotherapy did not improve overall survival, local recurrence was reduced (hazard ratio [HR] 0·45 [95%CI 0·20 to 0·99]), with an absolute benefit of just under 2%.1 With improving outcomes in modern breast cancer therapy, such incremental gains must be weighed against the burden of treatment-related toxicity. In this regard, Galina Velikova and colleagues2 are to be commended for their successful effort to include patient-reported quality of life (QOL) as a key component of the SUPREMO trial.

Randomised trials in rare cancers are scarce, and those that achieve adequate enrolment and methodological rigour warrant recognition. Upper tract urothelial carcinoma, which comprises only 5–10% of urothelial malignancies, presents unique challenges for trialists because of its low incidence and heterogeneous presentation. Despite its rarity, however, upper tract urothelial carcinoma carries a disproportionately high risk of bladder recurrence after radical nephroureterectomy, affecting 22–47% of patients in contemporary series.

For patients with high-risk, BCG-unresponsive, non-muscle-invasive bladder cancer with carcinoma in situ, therapeutic decision making remains challenging. Radical cystectomy offers the most reliable oncological control, but at the cost of major surgery, urinary diversion, and lasting effects on quality of life. Bladder-sparing approaches are therefore attractive, particularly if they provide durable disease control without compromising the opportunity for cure. Against this backdrop, the results of BOND-003 Cohort C reported by Mark Tyson and colleagues in The Lancet Oncology enter a rapidly evolving treatment landscape.

Radioactive iodine-refractory differentiated thyroid cancer remains a therapeutically challenging disease despite important advances over the last decade. Multi-kinase inhibitors targeting vascular endothelial growth factor receptor (VEGFR) signaling have improved progression-free survival compared with placebo,1–3 and these inhibitors are now considered standard of care for patients with locally advanced or metastatic disease.4 However, these therapies are associated with substantial toxicity, and durable responses remain uncommon.

Preoperative fluoropyrimidine-based chemoradiotherapy constituted the cornerstone in the management of locally advanced rectal cancer for more than two decades. Randomised trials established chemoradiotherapy followed by total mesorectal excision surgery as a standard approach, improving local control compared with radiotherapy alone and offering advantages, especially with regard to toxicity, over postoperative chemoradiotherapy. Despite these advances, distant metastases remained the predominant cause of treatment failure.

Gastric cancer remains a major cause of cancer mortality, and prognosis is particularly poor in individuals with peritoneal metastases.1,2 Although the integration of immunotherapy and targeted agents—such as trastuzumab or zolbetuximab—into systemic chemotherapy has improved survival in selected populations,3,4 treatment for these patients remains a clinical challenge, prompting the exploration of aggressive locoregional strategies.

In a post-hoc analysis of the PACIFIC trial published in The Lancet Oncology, Leonardo Brunetti and colleagues1 found that baseline proton pump inhibitor and antibiotic use was associated with worse progression-free survival in patients with stage III non-small-cell lung cancer (NSCLC) treated with durvalumab after chemoradiotherapy, but not in those treated with placebo. This treatment-specific effect suggests an interaction with immunotherapy that is potentially mediated by microbiome disruption.

Ward and colleagues1 offer a sophisticated simulation of 17 cancer typesacross 200 countries. The authors’ projections of persistent survival disparities are likely correct in direction (ie, Africa and Asia have lowest survival, North America and Oceania have highest survival). However, the model's architecture raises concerns that warrant scrutiny, not to dismiss the work, but to ensure policy influence is proportionate to evidentiary weight.

We thank Atif Kamal for his engagement and agree that investment in population-based cancer registries is important, especially when data are scarce.

Varey AHR, Weitemeyer MB, Gjorup CA, Lo SN, Williams GJ, Thompson JF. Assessment of survival benefit from sentinel node biopsy for melanoma: a systematic review and meta-analysis. Lancet Oncol 2026; 27: 452–60—In this Article, the PROSPERO registration number stated in the Summary and main text Methods should have been CRD42023494671. This correction has been made as of July 27, 2026.

The Royal College of Physicians (RCP) is calling upon the UK Government to address the nation's air pollution as a public health emergency, and not simply an environmental issue.

The 2026 G7 meeting of world leaders was held June 15–17 at Évian-les-Bains, Haute-Savoie, France, and hosted by President Emmanuel Macron of France. But among the usual high level political talks was a surprise announcement—a call to action on cancer. The leaders of the G7 nations of Canada, France, Germany, Italy, Japan, the UK, and the USA—together with this meeting's guest nations of Brazil, Egypt, India, Kenya, and South Korea—issued the statement committing to “deepen international scientific cooperation, close persistent gaps in prevention and early detection, and ensure that progress in oncology reaches every patient”.

In June, 2026, a Working Group of 23 scientists from 13 countries met at the International Agency for Research on Cancer (IARC) in Lyon, France, to finalise their evaluation of the carcinogenicity of butyl benzyl phthalate (BBzP), dibutyl phthalate (DBP), and diisononyl phthalate (DINP).

Although substantial progress against cancer has been made by the USA over the past several decades, cancer-related disparities remain a crucial public health challenge in the country, suggests the Cancer Disparities Progress Report 2026, released by the American Association for Cancer Research (AACR; Philadelphia, PA, USA) on June 24, 2026.

South Africa's completion of its first imPACT Review has raised hopes that long-standing gaps in cancer care could be translated into a new national cancer control plan, but clinicians and advocates caution that its value depends on whether it leads to funded implementation across the country's fragmented health system.

Addressing the persistent increase in rates of overweight, obesity, and physical inactivity in children and adolescents living in the WHO Americas Region, the Pan American Health Organization (PAHO) and the Organization of American States (OAS; Washington, DC, USA) have released new guidelines to assist countries in the region in developing, executing, monitoring, and assessing policies that foster healthy eating and physical activity in school environments.

The expansion of colorectal cancer screening in Ontario, Canada, has coincided with new evidence showing that registered First Nations people experience higher colon cancer incidence at younger ages and poorer survival after breast, cervical, and colon cancer diagnoses than other residents.

Effective cancer control depends on the coordinated functioning of multiple interlocking systems, including regulation, workforce planning, research collaboration, supply chains, and clinical infrastructure. Disruption in any of these can have downstream consequences for cancer outcomes, making the field particularly sensitive to structural, political, and policy changes.

Trastuzumab rezetecan improved progression-free survival versus pyrotinib plus capecitabine and showed a distinct safety profile in patients with HER2-positive breast cancer, presenting as a potential new treatment option.

Switching to camizestrant plus CDK4/6 inhibitor at ESR1 mutation emergence, versus continuing aromatase inhibitor plus CDK4/6 inhibitor, resulted in sustained progression-free survival benefit that translated into a statistically significant improvement in second progression-free survival. These results further support switching endocrine treatment to camizestrant from aromatase inhibitor upon detection of ESR1 mutation, with continuation of any of the globally approved CDK4/6 inhibitor, to extend first-line treatment benefit.

The 5-year QOL findings showed worse chest wall toxicity and no effect on other QOL domains. The subgroup analyses suggested a potential negative effect of chemotherapy and axillary clearance after sentinel node biopsy.

A single, postoperative pirarubicin instillation after radical nephroureterectomy is an efficacious treatment with manageable adverse events to reduce recurrence in patients with upper tract urothelial carcinoma.

Cretostimogene showed clinically meaningful anti-tumour response, with an adverse event profile characterised predominantly by low-grade, transient events. Cretostimogene shows promise as an innovative bladder-sparing treatment for high-risk, BCG-unresponsive, non-muscle-invasive bladder cancer with carcinoma in situ.

In previously-treated patients with locally advanced or metastatic, radioactive iodine-refractory BRAFV600E-positive differentiated thyroid cancer, dabrafenib plus trametinib showed significant benefits for progression-free survival and overall response rate, with no new safety signals. These findings support the second-line use of dabrafenib plus trametinib in patients with radioactive iodine-refractory BRAFV600E-positive differentiated thyroid cancer.

For MRI-defined, high-risk, locally advanced rectal cancer, the addition of irinotecan to standard of care did not improve outcomes and should not be used in combination with radiotherapy plus capecitabine.

In patients with dMMR or MSI-H locally advanced colorectal cancer, neoadjuvant toripalimab plus celecoxib significantly increased the proportion of patients attaining pathological complete response compared with toripalimab monotherapy, with a similar safety profile. These findings support further investigation of this combination strategy in larger phase 3 trials.

Gastrectomy with cytoreductive surgery and HIPEC provided no survival benefit in patients with gastric cancer and limited peritoneal metastases compared with systemic therapy alone.

Baseline exposure to proton pump inhibitors and antibiotics was associated with inferior outcomes with durvalumab, but not with placebo, consistent with potential attenuation of the benefit of durvalumab with proton pump inhibitors and antibiotics in patients with unresectable stage III NSCLC.

Cancer incidence and mortality are rising globally, with their burden falling disproportionately on low-income and middle-income countries. Africa faces major gaps in oncology education and workforce development, limiting access to high-quality cancer care. Focusing on efforts relevant to oncology in Africa, we provide an overview of existing programmes and models for educating health-care personnel in resource-constrained regions, highlighting challenges and effective strategies. Current efforts described include formal curricula, fellowship programmes, mentorship networks, and technology-driven solutions such as e-learning and telemedicine.

The rigorous conduct of well designed clinical trials is critical to improving outcomes for patients with gynaecological cancers. The Gynecologic Cancer InterGroup (GCIG) has promoted collaboration and harmonisation to guide clinical trials in ovarian and endometrial cancer through a series of consensus meetings with published statements. GCIG convened the inaugural Cervical Cancer Consensus Conference in Clinical Research in Dublin, Ireland, on Oct 14–15, 2024, to develop a consensus on design elements, essential questions, and unmet needs in cervical cancer research.

Somatostatin receptor PET imaging is integral to the management of patients with neuroendocrine tumours (NETs), yet standardised criteria for therapy response assessment with the use of this modality are not available. This Policy Review reports the development of the European Neuroendocrine Tumor Society somatostatin receptor PET response assessment framework, established through a structured modified Delphi process coordinated by the European Neuroendocrine Tumor Society. 34 international experts from nuclear medicine, radiology, oncology, endocrinology, surgery, and related disciplines participated in four iterative rounds evaluating 76 statements, with consensus defined as at least 75% agreement.

DFS demonstrated a strong association with OS and may serve as a valid trial‐level surrogate end point patients with in localized RCC. A DFS HR <0.914 was more likely to predict an OS benefit. These findings support the use of DFS as a primary end point in localized RCC trials, whereas continued long‐term follow‐up and future patient‐level validation remain important.

In a real‐world mCSPC setting, achieving a PSA of <0.2 ng/mL (whether or not a PSA decline of 90% was reached) within 9 months of initiating ADT ± other treatments was associated with improved OS, which supports a PSA nadir of <0.2 ng/mL for optimizing mCSPC outcomes.

Although this study confirmed the protective effects of post‐diagnostic BP use on risks of mortality among HR+ cases, further studies are required to prove the effects of post‐diagnostic BP use among TNBC participants.

CAYA cancer survivors demonstrate less sexual activity and condom use than controls. Higher treatment intensity is associated with less birth control use, suggesting potential misaligned fertility perceptions. Survivorship programs should integrate structured sexual health counselling.

Women, girls, and people assigned female at birth still face major shortfalls in health care because of their sex and gender, and classical haematology is no exception. A major disparity between males and females is the much longer time that females wait to be diagnosed with a bleeding disorder (2 years in males vs 14–16 years in females) leading to untreated chronic and acute bleeding events that can be debilitating and even life threatening. Other challenges that affect physiological processes unique to women, girls, and people assigned female at birth include under-recognition of heavy menstrual bleeding, inconsistent definitions and management plans for post-partum haemorrhage, and poor optimisation of hormone therapy and anticoagulation in hormone therapy-associated and pregnancy-associated thrombosis.

Improving access to menstrual health requires expanded attention and investment in a diversity of areas grounded in its definition. These areas range from increasing menstrual health literacy to commonplace menstrual-friendly public toilets, menstrual-supportive schools, workplaces, and public spaces, as well as improved preventive care and treatment from menarche to menopause, including the recognition that heavy menstrual bleeding occurs frequently in patients with bleeding disorders. The Lancet Haematology Commission1 by Luuk J J Scheres and colleagues highlights crucial areas needing attention for a range of menstrual health-related issues.

Maria Bouzani (Athens, Greece) and colleagues presented results from a phase 1b study (NCT04884035) assessing the safety and preliminary activity of golcadomide (first-in-class, oral Cereblon E3 Ligase Modulatory Drug) plus polatuzumab-RCHP in patients with newly diagnosed aggressive B-cell lymphoma. 57 patients received the regimen for six 21-day cycles; in the dose-escalation phase, golcadomide was dosed at 0·2 mg (n=28) or 0·4 mg (n=29) orally on days 1–7, and in the dose-expansion phase, patients were randomly assigned to either dose.

Postpartum haemorrhage remains a leading cause of maternal mortality worldwide, accounting for 27% of global maternal deaths with approximately 80% of related deaths occurring in low-income and middle-income countries (LMICs), particularly in sub-Saharan Africa and south Asia. Multiple systemic factors, including shortages of skilled health personnel, limited access to antenatal care, delays in referral, inadequate supplies of essential medicines and commodities, and insufficient blood transfusion services contribute to the incidence of postpartum haemorrhage and its associated poor outcomes.

During my transition as a transgender individual, I experienced something that I had been warned about in advance. Deep down I had always thought that will not happen to me. My health-care team had warned me that the medication, especially the hormones containing oestradiol, could increase the risk of dangerous blood clots. I heard the words they said, I realised what they meant, yet it felt far away. On the one hand, I realised there were risks and I did not want to seem self-focused to those around me and wanted to make a responsible choice.

To our knowledge, this is the largest study on HCT for Hodgkin lymphoma in recent years, and our findings that outcomes after auto-HCT and allo-HCT improved over time provide relevant information that could set the basis for prospective trials or additional studies.

Low-dose ruxolitinib, used in place of mycophenolate mofetil within a backbone of prophylactic antithymocyte globulin, calcineurin inhibitor, and short-course methotrexate, reduced grade II–IV acute GVHD by day 100 after haploidentical HSCT and had manageable toxicity. These findings support further evaluation of targeted JAK1/2 inhibition as part of GVHD prophylaxis.

Venetoclax with high-dose cytarabine is active with acceptable safety in paediatric patients with relapsed or refractory AML. These findings support ongoing research of venetoclax with high-dose cytarabine in this population, including the randomised paediatric phase 3 trial (NCT05183035).

Women and girls, who make up more than 50% of the population worldwide, lag behind men in a long list of health metrics, with a higher burden of morbidity-driven conditions, undertreatment of pain, and delayed diagnoses.1,2 In particular, women and girls have unique presentations and consequences of haematological disorders, with higher rates of anaemia, unique and greater symptom burden from bleeding disorders due to sex-specific bleeding challenges, and pregnancy-related thrombotic and bleeding complications.

A man aged 46 years with no history of cardiac disease presented with pancytopenia to Osaka General Medical Center, Osaka, Japan, in June 2025. Bone marrow examination confirmed a diagnosis of acute promyelocytic leukaemia. The PML–RARA rearrangement was identified through RT-PCR. Laboratory data indicated low-risk disease based on the Sanz score (leucocytes 0·6 × 109 cells/L and platelets 42 × 109 cells/L). Induction therapy with all-trans retinoic acid (ATRA; 45 mg/m2 per day given orally) was initiated.

Since the first approval of a filgrastim product in 2015, many biosimilars have come on the marker for hematology indications. Herndon, Brahme, and Ricci present the scientific rationale for replacing comparative efficacy studies, previously used by the US Food and Drug Administration for approvals, with comparative analytical assessments, arguing that modern analytical methods are more sensitive than clinical trials for detecting meaningful differences between biosimilars and reference products. They highlight how this regulatory shift could accelerate biosimilar availability for hematologic malignancies while reducing unnecessary clinical studies.

In patients with hypocellular bone marrow failure (BMF), disease-specific somatic alterations can help distinguish among different etiologies, including immune-mediated aplastic anemia, inherited BMF syndromes, and hypoplastic myelodysplastic syndrome. Groarke, Gutierrez-Rodrigues, and Patel discuss how they incorporate somatic alterations into their diagnostic approach. Through a series of illustrative cases, they demonstrate how these alterations can also predict the risk of secondary myeloid neoplasms, guide surveillance strategies, and, for selected patients, facilitate early therapeutic intervention.

Patients with relapsed or refractory multiple myeloma and extraosseous extramedullary disease have poor outcomes. Zhou et al report dual-targeted anti-BCMA/GPRC5D chimeric antigen receptor (CAR) T cells that achieve an overall response rate of 97%, universal bone marrow measurable residual disease negativity among responders, and a stringent complete response rate of 43%, with toxicities comparable to those of single-target CAR T-cell products. Despite these impressive early responses, durability remains limited, highlighting the challenge of achieving long-term disease control in this high-risk population.

Hematopoietic stem cells (HSCs) rely on specialized niche cells for their maintenance, and the coordinated interactions among these cellular regulators are essential for sustaining hematopoiesis. Xu et al provide evidence that cross talk between endothelial cells (ECs) and mesenchymal stromal cells (MSCs) through Notch signaling is required to maintain HSCs and promote regeneration of the hematopoietic system after injury. Their study identifies a critical role for Notch signaling in mediating EC-MSC communication and regulating HSC function, while reinforcing previous observations that Notch signaling is a central regulator of angiogenesis, osteogenesis, and hematopoiesis.

Lenalidomide treatment for multiple myeloma is associated with an increased risk of secondary B-cell acute lymphoblastic leukemia (B-ALL). Horns et al performed a comprehensive molecular characterization of 57 cases, demonstrating that IDH2 mutations are highly enriched in lenalidomide-associated B-ALL (23%). Their analyses suggest that these mutations were selected from preexisting clonal hematopoiesis, underscoring the need for continued investigation into the interplay between immunomodulatory therapies and the risk of clonal hematopoiesis progressing to overt leukemia.

The mechanisms by which IDH1 mutations promote acute myeloid leukemia (AML) remain incompletely understood. Hakobyan et al demonstrate that mutant IDH1 induces an early neutrophil differentiation block through epigenetic repression of Cebpe, defining a key mechanism linking IDH1 mutations to leukemogenesis. These findings identify potential biomarkers and therapeutic targets for IDH1-mutant AML.

Polycomb repressive complex 1 (PRC1) and PRC2 regulate the fetal-to-adult hemoglobin switch, and reversing this process is a promising therapeutic strategy for sickle cell disease and β-thalassemia. Kaminski et al use a comprehensive CRISPR-based screen to interrogate the components of these repressive complexes and identified a single protein domain in EZH2, a subunit of PRC2, as a potential therapeutic target. They demonstrate that inhibition of the domain encoded by exon 14 of EZH2 selectively derepresses fetal hemoglobin expression, raising the possibility of developing drugs that specifically target this domain to treat hemoglobinopathies.

With the availability of 2 commercial gene therapies and improved outcomes with haploidentical transplantation, patients with sickle cell disease (SCD) now have several potentially curative treatment options. Chetlapalli et al report a cost-effectiveness analysis comparing nonmyeloablative haploidentical transplantation, gene therapy, and standard care in adults and children with SCD. At current prices, haploidentical transplantation is the most cost-effective strategy. This analysis provides valuable guidance for clinicians, patients, and health systems as they consider treatment choices. However, as Kelkar and Antin conclude in their accompanying Blood Commentary, the true measure of success is not which therapy “wins” the economic argument, but whether each patient receives the therapy best suited to their clinical needs and values.

Next-generation sequencing (NGS) FLT3-internal tandem duplication (ITD) measurable residual disease (MRD) testing for patients in remission from acute myeloid leukemia is now recommended by the recently updated clinical standard-of-care guidelines. Hourigan et al provide important laboratory and clinical recommendations regarding such testing, focusing on how and when to do it as well as how to interpret the results.

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New England Journal of Medicine, Ahead of Print.

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New England Journal of Medicine, Ahead of Print.

New England Journal of Medicine, Ahead of Print.

In a post hoc analysis of the global phase III TOPAZ-1 trial published in JAMA Oncology, Oh et al found that the addition of durvalumab to chemotherapy with gemcitabine and cisplatin was associated with long-term survival benefit and a clinically manageable safety profile in patients with...

In a Chinese phase II trial reported in the Journal of Clinical Oncology, Li et al found that the first-line combination of disitamab vedotin, tislelizumab, and S-1 was associated with high activity in patients with HER2-overexpressing advanced gastric/gastroesophageal junction (GEJ)...

As reported in The Lancet Oncology by Brunetti et al, a post hoc analysis of the phase III PACIFIC trial showed that baseline exposure to proton pump inhibitors and antibiotics was associated with inferior outcomes among patients with unresectable stage III non–small cell lung cancer (NSCLC)...

Dynamic surveillance using circulating tumor DNA (ctDNA) methylation testing after curative-intent surgery significantly increased the proportion of patients with recurrent nonmetastatic colorectal cancer who were able to undergo curative-intent treatment, according to results of the phase III FIND ...

Patients with androgen receptor (AR)–positive salivary gland carcinoma treated with darolutamide plus goserelin experienced greater antitumor activity than those treated with darolutamide alone in the Japanese phase II DISCOVARY trial, while both approaches demonstrated manageable safety profiles...

Researchers have discovered that immunosuppressed patients with nonmelanoma skin cancer are not missing the key immune cells found in immunocompetent patients, but that those cells, or macrophages have lost the ability to communicate effectively. This new understanding may help researchers develop...

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...

Residential context showed a significant relationship with survival among Black women diagnosed with epithelial ovarian cancer, according to study findings published in JAMA Network Open. Black women who lived in more socially vulnerable communities faced higher risks of death than those in less...

Above 80% of cancer care providers globally report a lack of knowledge regarding integrative oncology treatments that prevent them from offering these services to patients, according to survey findings published in Supportive Care in Cancer. 

A histology-based artificial intelligence (AI) biomarker may help personalize adjuvant chemotherapy selection for patients with resected pancreatic ductal adenocarcinoma, according to the results of a study by Beaufils et al. The investigators developed and validated a deep learning model that...

In a phase Ib study published in the Journal of Clinical Oncology, Zhao et al found that the first-in-class bispecific antibody-drug conjugate (ADC) izalontamab brengitecan (iza-bren, BL-B01D1) demonstrated antitumor activity in patients with relapsed extensive-stage small cell lung cancer,...

A research project funded by the National Institutes of Health (NIH), with collaborators around the country and the world, has generated extensive and diverse collections of patient-derived tumor models. Tumor tissue from patients with cancer contributed to the compendium of tumor models that will...

Pamela Munster, MD, joined the Stanford Cancer Institute as the inaugural Associate Director for Early Detection and Interception Research on August 1, 2026. She also assumed a faculty appointment as a Professor in the Stanford Medicine Division of Oncology. 

On July 31, the U.S. Food and Drug Administration (FDA) approved lutetium-177–labeled PSMA-617 (vipivotide tetraxetan, also known as LuPSMA-617; Pluvicto), a targeted radionuclide therapy, in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific...

On July 14, the U.S. Food and Drug Administration (FDA) granted traditional approval to selpercatinib (Retevmo), an oral RET inhibitor, for adult and pediatric patients aged 2 years and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved...

Survivors of hematopoietic cell transplant (HCT) are at increased risk of skin cancer and screening for early detection is encouraged. New research published by Armenian et al in JNCCN—Journal of the National Comprehensive Cancer Network shows how a technology enabled, remotely delivered,...

The American College of Surgeons' (ACS) Commission on Cancer (CoC) has introduced a Rural Cancer Program Accreditation, providing a new accreditation pathway tailored to hospitals in rural counties, thereby expanding access to high-quality cancer care for individuals living in rural communities.  

In a multicenter Chinese randomized phase III trial published in the Journal of Clinical Oncology, Wang et al found that an intensified total neoadjuvant therapy approach integrating long-course radiotherapy with uninterrupted capecitabine and oxaliplatin chemotherapy improved disease-free survival ...

In the phase III MajesTEC-9 trial, monotherapy with the bispecific antibody teclistamab kept disease under control substantially longer and improved overall survival compared with investigator’s choice of pomalidomide/bortezomib/dexamethasone (PVd) or carfilzomib/dexamethasone (Kd) in patients with ...

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

In premenopausal women under the age of 55 years with hormone receptor–positive, HER2-negative, node-positive breast cancer, investigators reported that those with low baseline levels of anti-Mullerian hormone (AMH) did not benefit from adjuvant chemotherapy and endocrine therapy. The findings from ...

Cancer is the second leading cause of death globally, after cardiovascular disease, and claims more than 26,000 lives daily, according to a report from the WHO Global Status Report on Cancer 2026, developed jointly with the International Agency for Research on Cancer (IARC). The report was issued...

On August 6, the U.S. Food and Drug Administration (FDA) granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who...

In the phase III HORIZON-Breast01 trial, the HER2-directed antibody-drug conjugate trastuzumab rezetecan significantly improved progression-free survival and showed a distinct safety profile vs pyrotinib plus capecitabine in HER2-positive metastatic breast cancer. The interim analysis, reported by...

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.

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.

Benefit from perioperative enfortumab vedotin–pembrolizumab in cisplatin-eligible MIBC

In MonumenTAL-3, the G-protein-coupled receptor class C group 5 memberD-directed bispecific T cell engager talquetamab combined with either daratumumab or daratumumab–pomalidomide conferred significantly longer progression-free survival than daratumumab–pomalidomide–dexamethasone in patients with relapsed and/or refractory multiple myeloma (≥1 prior line of therapy). These results herald a new therapeutic option for such patients but also raise questions regarding how talquetamab-based regimens should be integrated with B cell maturation antigen-directed T cell-redirecting therapies.

With the expanded use of antibody–drug conjugates (ADCs) and immune checkpoint inhibitors (ICIs) in combination, clinicians increasingly face overlapping toxicity profiles with uncertain attribution. The authors of this Review propose a framework that links three interacting layers: immune activation, payload cytotoxicity and payload-independent effects, and provide practical algorithms for evaluation, initial management and treatment resumption in patients receiving ADC monotherapy or ICI–ADC combinations.

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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.

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

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

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

Taiho Pharmaceutical and Cullinan Therapeutics’ cancer asset is already under FDA review in a later setting, with a decision expected by February.

It’s smooth sailing for Definium Therapeutics as the psychedelic biotech charts another win for its LSD candidate, this time in anxiety. The psychedelic previously notched a late-stage victory in depression.

Definium Therapeutics’ closely watched anxiety readout could further validate its single-dose LSD candidate, while Compass Pathways advances a psilocybin program through a rolling FDA filing.

Patients treated with Tenax Therapeutics’ heart failure drug TNX-103 did not show significantly better functional performance—though Leerink analysts found biomarker improvements and subgroup analyses in elderly and more severe patients “very encouraging.”

Strong quarterly results are prompting Bristol Myers Squibb to lift its 2026 outlook, though the company is facing another delay for key Cobenfy Alzheimer’s data and a pushed-back readout for milvexian.

Summit Therapeutics revealed positive Western data last week from a Phase 3 trial of lung cancer candidate ivonescimab. In a flipped geographical clinical trials landscape, what more will be required for Summit and China-based partner Akeso—and other transnational tandems—to secure FDA approval?

Sanofi had hoped the acquisition of Kymab would fill a major hole that will be left as autoimmune juggernaut Dupixent heads toward a patent cliff. Now, another therapy has failed to meet expectations.

With weight loss topping 20% at 80 weeks in the Phase 3 TRIUMPH-2 and TRIUMPH-3 trials, Eli Lilly plans to file for retatrutide’s approval in the first quarter of 2027. Previously a filing was expected later this year.

Summit Therapeutics and Akeso are answering questions raised about ivonescimab’s ability to translate to Western populations, though the partners have yet to share if the new findings are statistically significant.

With Phase 3 data showing what analysts called a “potentially best-in-class profile,” Arrowhead Pharmaceuticals plans to submit for FDA approval of plozasiran by the end of the year—hoping to follow to market Ionis Pharmaceuticals’ Tryngolza, which got the regulator’s nod in severe hypertriglyceridemia last month.

Taiho Pharmaceutical and Cullinan Therapeutics’ cancer asset is already under FDA review in a later setting, with a decision expected by February.

In this episode of Denatured, you’ll hear from Diana Saraceni, founder and managing partner at Panakès Partners and Fabrizio Calisti, medical director at Angelini Ventures. We explore how Italy’s life sciences ecosystem has evolved over the last decade—from stronger tech transfer and growing venture capital to the gaps that still keep it from matching the UK, Germany or France in company creation and scale.

It’s smooth sailing for Definium Therapeutics as the psychedelic biotech charts another win for its LSD candidate, this time in anxiety. The psychedelic previously notched a late-stage victory in depression.

The national growth vehicle isn’t biotech‑dedicated, but channeling capital toward life sciences would amplify Austria’s strong research hubs, nondilutive funding landscape and reputation as a champion in science and technology.

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.

Definium Therapeutics’ closely watched anxiety readout could further validate its single-dose LSD candidate, while Compass Pathways advances a psilocybin program through a rolling FDA filing.

Patients treated with Tenax Therapeutics’ heart failure drug TNX-103 did not show significantly better functional performance—though Leerink analysts found biomarker improvements and subgroup analyses in elderly and more severe patients “very encouraging.”

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.

In this episode of Denatured, you’ll hear from Hans Eriksson, chief medical officer at FundaMental Pharma and Steve Levine, chief patient officer at Compass Pathways. We explore why treatment-resistant depression remains so difficult to address, and how new approaches—from rapid-acting antidepressants to psychedelic therapy—may reshape the treatment paradigm.

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. 

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

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

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