When patients, or the parents of patients, become heavily invested in searching for someone to blame for an illness, it’s useful to ask what the search is doing for them. Its accuracy is rarely the point.

A 19-year-old man with a history of splenectomy presented with chest-wall pain. Multiple enhancing soft-tissue deposits in the omentum and perirectal space were seen on CT of the abdomen and pelvis.

In patients with EGFR-mutated and MET-altered non–small-cell lung cancer that had progressed during osimertinib therapy, osimertinib plus savolitinib (a MET tyrosine kinase inhibitor) led to longer survival than platinum–pemetrexed.

In patients with previously treated advanced non–small-cell lung cancer with a KRAS G12C mutation, median progression-free survival was 9.8 months with the KRAS G12C inhibitor divarasib and 5.7 months with sotorasib or adagrasib.

Among patients with PD-L1–negative advanced nonsquamous non–small-cell lung cancer, progression-free survival was longer with sacituzumab tirumotecan plus pembrolizumab than with chemotherapy plus pembrolizumab (15.0 vs. 5.7 months).

In patients with muscle-invasive bladder cancer, event-free survival at 24 months was 63.5% with perioperative durvalumab plus neoadjuvant enfortumab vedotin as compared with 45.1% with surgery alone.

Among patients with HER2-positive advanced breast cancer, the HER2-targeted bispecific antibody anbenitamab plus albumin-bound docetaxel led to 24-month progression-free survival of 58.5%, as compared with 34.4% with standard therapy.

In a prespecified interim analysis of a phase 3 trial involving patients with extensive-stage SCLC, the median overall survival was 21.1 months with tarlatamab–durvalumab maintenance therapy and 12.7 months with durvalumab alone.

Scientific progress in oncology has been substantially advanced through mechanistic discovery. Human epidermal growth factor receptor 2 (HER2) was first established as an oncogenic driver by Slamon et al. in 1987, a discovery that catalyzed the development of highly effective, life-prolonging targeted therapies.1 Substantial progress has since been...

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 discovery of H. pylori has advanced the prevention and treatment of gastritis, peptic ulcers, and gastric cancer. Progress has been made in the research of H. pylori infection. These advances are discussed in this review.

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.

A 52-year-old man with metastatic small-cell lung cancer was evaluated in the ophthalmology clinic because of vision loss in the left eye. A blood cytomegalovirus DNA viral load was 348 IU per milliliter. A diagnosis was made.

In a phase 1 study, RXRG001, a circular RNA encoding aquaporin-1, was administered to six patients with radiation-induced xerostomia. Measures of salivary flow improved, and adverse events were of grade 1 or 2 and transient.

In a trial involving adults with Ph-positive acute lymphoblastic leukemia, 24-month event-free survival was 86% with the TKI–immunotherapy combination ponatinib–blinatumomab and 67% with imatinib plus chemotherapy.

In a phase 3, randomized trial of lonvo-z, an in vivo gene-editing therapy, patients with hereditary angioedema who received the drug had a significantly lower attack rate than those who received placebo.

A 39-year-old man, who was an Iraq War veteran with exposure to burn pits, was admitted to the hospital with hypertension, abdominal pain, and foot drop. Imaging showed a thoracic spinal mass. A diagnosis was made.

A 44-year-old man was admitted for the management of carcinoid syndrome, which had been diagnosed 4 years earlier. On examination, mottled, violaceous, blanchable flushing was seen across the face and torso.

Hereditary angioedema is a disorder characterized by unpredictable, transient episodes of swelling and pain of various body parts. It can be life-threatening if the airway is involved. Current therapies include several different products that are administered prophylactically or at the onset of symptoms, and the prophylactic products must be administered...

The 21st volume of the IARC Handbooks summarizes and evaluates evidence for the benefits and harms of lung cancer screening with low-dose CT or chest radiography and assesses tools and strategies to improve screening.

The benefit of exercise alongside cancer treatment and recovery has primarily rested on association. However, two randomised trials, CHALLENGE and STAMINA, now supply the causal evidence that exercise oncology lacked. The pressing question is now one of implementation. STAMINA has already led to free exercise programmes for men undergoing treatment for prostate cancer in the UK and the European Society for Medical Oncology has updated their guidelines as a result of the CHALLENGE study.

The introduction of thalidomide and its derivatives—lenalidomide, followed by pomalidomide—has improved the therapeutic arsenal for multiple myeloma for more than two decades. These immunomodulators bind to cereblon, a component of the CRL4-cereblon E3 ubiquitin ligase complex, which results in the targeted degradation of the transcription factors Ikaros and Aiolos.1,2 Iberdomide belongs to the next generation of drugs, known as cereblon E3 ligase modulators. Its chemical structure is extended by an additional benzyl moiety bearing a morpholine group—which increases the molecular volume and the contact surface with cereblon, thereby enhancing its affinity and degradation potency compared with conventional immunomodulators.

51 (96%) of 53 countries in the WHO European Region have national breast cancer screening programmes. Globally, 63% of all nations have established breast cancer screening programmes.1 Most of the European screening programmes are organised nationally and are population-based, focusing on women older than 50 years.1 Full-field digital mammography is the gold standard screening modality used in these programmes because of its clinical efficiency and cost-effectiveness.2

Cancer poses a disproportionate disease burden across different country populations. Beyond large international differences in cancer incidence, cancer survival varies globally, even between countries within the same continent or among those with publicly funded health-care systems.1–3 Therefore, much research in recent years has rightly focused on how countries with a relatively poor record in cancer control could narrow the gap separating them from high-performing peers.

Every year, pivotal clinical trials are reported, showing major advances in cancer treatment. At the American Society of Clinical Oncology (ASCO) 2026 conference, results from the RASolute302 trial for patients with advanced pancreatic cancer established daraxonrasib, a RAS(ON) inhibitor, as a watershed moment in oncology.1 Among previously treated patients, daraxonrasib improved median overall survival by 7 months compared with chemotherapy and improved quality of life. Given that pancreatic cancer is among the most lethal of all cancers, the target was hitherto considered undruggable, and that the disease is accompanied by considerable suffering, this treatment was appropriately celebrated as a landmark success of drug development.

Radionuclide theranostics is transforming oncology by enabling more personalised treatment based on tumour biology. The approach pairs tumour-specific vectors with diagnostic and therapeutic radionuclides. Theranostics enables clinicians to confirm tumour targeting via molecular imaging before delivering targeted radiation with the same vector. Over the past decade, this approach has transformed treatment for neuroendocrine tumours and prostate cancer and is now expanding into additional malignancies and earlier stages of disease.

The majority of children diagnosed with cancer do not have access to essential medicines.1 To address this reality, the Global Platform for Access to Childhood Cancer Medicines (Global Platform) was launched in February, 2025, by WHO and St Jude Children's Research Hospital, in collaboration with UNICEF and the Pan American Health Organization (PAHO).2

Nicholas C Turner and colleagues1 report extended SERENA-6 results showing sustained benefit in progression-free survival (hazard ratio [HR] 0·45, 95% CI 0·34–0·59; nominal p<0·0001) and improved second progression-free survival (HR 0·63, 0·46–0·86; p=0·0037) after switching from an aromatase inhibitor to camizestrant when ESR1 mutations were detected in circulating tumour DNA (ctDNA).1 These findings support ESR1 mutation as an actionable biomarker. However, treatment efficacy in patients with detected ESR1 mutations does not, by itself, establish the population-level utility of serial surveillance, which depends on its intended use and net effects across all patients tested.

We read with great interest the BOND-003 Cohort C results reported by Mark D Tyson and colleagues,1 showing durable complete responses with intravesical cretostimogene grenadenorepvec in patients with high-risk, BCG-unresponsive, non-muscle-invasive bladder cancer with carcinoma in situ.

Mark D Tyson and colleagues1 report centrally confirmed complete response at any time in 83 (75%) of 110 efficacy-evaluable patients receiving intravesical cretostimogene grenadenorepvec for BCG-unresponsive, carcinoma in situ-containing non-muscle-invasive bladder cancer in BOND-003 Cohort C. They also report cystectomy-free survival of 89% at 12 months and 81% at 24 months.1 These results are encouraging. However, for patients considering bladder preservation, the relevant outcome is retention of the bladder without high-grade disease, rather than organ retention alone.

We thank Pietro Scilipoti and colleagues and Man Sun and colleagues for their interest in our Article on BOND-003 Cohort C.1

Kirby AM, Finneran L, Griffin CL, et al. Partial-breast radiotherapy after breast conservation surgery for women with early breast cancer (UK IMPORT LOW): 10-year outcomes from a multicentre, open-label, randomised, controlled, phase 3, non-inferiority trial. Lancet Oncol 2025; 26: 898–910—In this Article, in table 1, the row of data for the reduced-dose group under the heading Any breast cancer event (intention-to-treat population) has been amended. In the third paragraph of the Results, sentence three should have read “63 (3%) participants developed contralateral breast primary cancers (24 [4%] in the whole-breast group, 20 [3%] in the reduced-dose group, and 19 [3%] in the partial-breast group), 53 (84%) of which were invasive...”, sentence four should have read “Non-breast second primary cancers were reported for 159 (8%) patients (62 [9%] in the whole-breast group, 57 [8%] in the reduced-dose group…”, sentence six should have read “Three breast angiosarcomas were reported...”, and sentence nine should have read “Breast cancer-related events of any kind were reported for 170 patients… with a 10-year breast cancer-free-interval in…91·8% (89·3–93·7) in the reduced-dose group…”.

Concin N, Matias-Guiu X, Cibula D, et al. ESGO–ESTRO–ESP guidelines for the management of patients with endometrial carcinoma: update 2025. Lancet Oncol 2025; 26: e423–35. The appendix of this Policy Review has been corrected as of Oct 26, 2026.

Malawi's National Cancer Centre, opened in July, 2025, with support from the International Atomic Energy Agency's (IAEA) Rays of Hope initiative, is intended to bring several cancer services together in one facility. The centre provides radiotherapy and brachytherapy, alongside surgery and chemotherapy, reducing the need for patients to seek different parts of their treatment elsewhere. The centre was among developments highlighted at the 70th IAEA General Conference, held at the Vienna International Centre on Sept 14–18, 2026, as countries discussed efforts to expand cancer diagnosis and treatment.

Earlier this month, India surpassed 8 million doses of the human papillomavirus (HPV) vaccine, Gardasil-4, administered under a nationwide campaign launched earlier this year. The Ministry of Health and Family Welfare described the milestone as an important step forward in their goal of reducing cervical cancer in a country that accounts for roughly a quarter of global deaths from the disease. Four states have already reached 100% coverage of their target populations. However, the national picture is uneven, and experts say sustaining momentum will require overcoming vaccine hesitancy, misinformation, and the logistical demands of reaching eligible girls across a vast and diverse country.

On Sept, 14, 2026, the US Environmental Protection Agency (EPA) under the Trump administration announced a rollback of Biden-era rules limiting greenhouse gas emissions from the country's coal-burning and gas-fired power plants. The EPA also proposed scrapping all other greenhouse gas emissions rules for the power sector implemented by the Biden administration, arguing that the regulations exceeded the agency's authority under the Clean Air Act.

A 6 month landscape assessment has explored whether Brazil could use its tuberculosis and primary health-care infrastructure to detect lung cancer earlier. The assessment covered three states (Rio de Janeiro, Pernambuco, and Amazonas) and was conducted by PATH and Global Health Strategies. The project was funded by the Bristol Myers Squibb Foundation.

The UK Government has formed a new National Cancer Board to drive delivery of its 2026 National Cancer Plan, a strategy blueprint aimed at transforming cancer care and outcomes in England by 2035.

Viet Nam's Ministry of Health wants to add screening and early diagnosis for seven cancers to services reimbursed by the Health Insurance Fund, potentially shifting a system that has largely financed cancer care after diagnosis towards earlier detection. But the draft decree would phase in coverage and leave the Ministry of Health to define target groups, services, and payment levels, with implementation tied to the fund's ability to pay.

Historically, prophylactic cranial irradiation (PCI) is associated with improved survival but increased neurological toxicity. Paul Brown (Mayo Clinic, Rochester, MN, USA) presented results from the phase 3 SWOG S1827 MAVERICK trial, comparing standard-of-care, PCI plus MRI, with MRI surveillance alone in 304 randomly assigned patients with limited and extensive-stage small-cell lung cancer (SCLC) who had completed initial therapy. The median follow-up was 22 months and the primary endpoint, cognitive failure-free survival, was significantly better in the MRI only group (HR 0·60, 90% CI 0·46–0·78; p=0·001).

On Sept 22, 2026, the US Government cancelled more than 760 000 people's government-subsidised health insurance policies, contending they were fraudulently obtained on the Federal Health Insurance Marketplace. As many as 440 000 other enrolments are still under investigation, officials said.

The proportion of the world's oncology trials delivered within Europe has fallen from 41% in 2008 to 21% in 2023, according to a new report by the European Cancer Organisation (ECO).

Cancer experts fear a rise in cancer cases in Russia if a draft 2027 budget proposing a sharp cut of more than 90% in federal cancer funding is pushed through parliament.

Some places shape not only the careers we build, but the people we become. For me, that place is the Cape Breton Cancer Centre (Sydney, NS, Canada). In 2001, I began my career as a radiation therapist, never imagining that this cancer centre would become one of life's greatest teachers.

It was a 2015 Editorial in The Lancet Oncology discussing cancer in the transgender community, that set Alison Berner (Queen Mary University of London, London, UK) on her unique career path.1 The Editorial cited a piece of research in people with HIV, which she realised meant there was no relevant papers in transgender people with cancer to draw on.

Joanne Tinker remembers searching online for what a mastectomy would look like, convinced she was about to be mutilated. She was not. The gap between fear and reality is what a new exhibition in Ilkley (UK) sets out to close.

Iberdomide, daratumumab, and dexamethasone significantly improved MRD-negative complete response compared with daratumumab, bortezomib, and dexamethasone. The most common grade 3 or grade 4 adverse events were haematological events and infections, which were mostly manageable with standard supportive care. These findings support iberdomide, daratumumab, and dexamethasone as an efficacious treatment option for patients with relapsed or refractory multiple myeloma with the potential to be administered across diverse care settings.

TOSYMA-2 indicates that about a quarter of invasive interval cancers occurring with digital mammography over 2 years might be avoided with digital breast tomosynthesis plus s2D mammography screening. Although the primary outcome of TOSYMA-2 did not reach statistical significance, this large, randomised trial adds substantial evidence to the use of digital breast tomosynthesis plus s2D mammography in breast cancer screening.

Our analysis suggests that NCCP comprehensiveness varies substantially between countries with consistent weaknesses in financing, outcome measurement, and contextual analysis. A shared health systems framework and scalable AI appraisal tools, such as PRISM, could support more complete, comparable, and actionable plans to strengthen cancer control globally by providing the possibility for rapid analysis of comprehensiveness of NCCPs and generation of timely, achievable, and evidence-informed, context-specific plans that use the latest data.

The risk–benefit ratio observed in the DALY 2-EU study supports consideration of zamto-cel as a second-line standard treatment option for patients with relapsed or refractory large B-cell lymphoma who are ineligible for transplantation.

Neoadjuvant niraparib showed anti-tumour activity and enabled R0 resection in selected patients with HRD-positive advanced ovarian cancer who were initially unsuitable for primary debulking surgery. This strategy remains investigational and requires randomised validation against standard platinum-taxane neoadjuvant chemotherapy.

These findings should be interpreted as evidence of associations not causality, suggesting differences in quantity uptake of essential cancer medicines along two structural dimensions: fewer countries showed uptake of essential cancer medicines in lower-GDP countries than in middle-GDP and high-GDP countries and medicines requiring complex genomic diagnostics had lower uptake, with the lowest uptake in lower-GDP countries. The results suggest that, as precision oncology medicines become increasingly represented in the WHO EML, EML inclusion alone could be insufficient to enable patient access.

In this interim analysis, short-course radiotherapy followed by camrelizumab and CAPOX significantly improved 3-year event-free survival in patients with locally advanced rectal cancer, with a safety profile similar to long-course chemoradiotherapy followed by CAPOX. Comparison of this promising new treatment strategy with contemporary total neoadjuvant therapy strategies is warranted.

Our findings indicate high variability of per-capita health expenditure on cancer control globally and generally low expenditure levels, particularly in lower-middle-income and low-income countries and territories. The paucity of publicly available expenditure data on cancer control indicates the need for production of detailed NHAs that include disease-specific expenditures to ensure availability of regular, comparable, and reliable data.

The goal of adjuvant systemic therapy after locoregional treatment of cancer is to increase the probability of cure by eradicating micro-metastases. Adjuvant treatment adds side-effects and can impair health-related quality of life (HRQOL); this must be balanced against a reduction in the probability of recurrence, which has a substantial negative effect on HRQOL. Since many adjuvant therapies lead to small gains in relapse-free or overall survival, the severity and duration of treatment-related side-effects and their impact on patient functioning and overall HRQOL are relevant to clinical decision making.

Up to 12% of childhood cancer survivors have an underlying cancer predisposition syndrome (CPS). As a result, these childhood cancer survivors are at increased risk for developing and succumbing to subsequent malignant neoplasms. Identifying childhood cancer survivors with CPS is essential to improving overall outcomes by informing tailored approaches to cancer screening, treatment, and, for some, risk-reducing interventions. Despite these potential benefits, it is often unclear which childhood cancer survivors warrant referral for genetic counselling and germline genetic testing.

Patients with de novo metastatic nasopharyngeal carcinoma were historically deemed incurable and treated with palliative intent. Emergence of potent systemic therapy in combination with local treatment for both locoregional and metastatic diseases has enabled long-term survival in some patients. This international guideline was developed through consensus-building by 54 experts from 46 centres across 18 countries or regions and endorsed by 17 oncology organisations. 32 recommendations across seven clinical domains were formulated, including 29 strong (≥80% agreement [consensus] or high quality of evidence) and three conditional recommendations (67–79% agreement).

Proton re‐RT demonstrated encouraging locoregional control and survival in heavily pretreated patients, although late toxicities remain important concerns (ClinicalTrials.gov identifier: NCT03217188).

This study failed to demonstrate a survival advantage after eltrombopag addition, at variance with previous reports, but shows that initiating eltrombopag after chemotherapy washout is feasible and safe, and resulted in a decreased need for platelet transfusions.

Postdiagnosis weight trajectory and metabolic health are important prognostic factors for nonmetastatic RCC. Weight stability and absence of diabetes were associated with more favorable outcomes. Incorporating repeated BMI measurements and diabetes status may improve risk stratification during RCC survivorship.

Outcomes were more favorable with the combination of chemotherapy and RT (pre‐ or postoperative) versus no RT for initially unresected NRSTS. Patients with large synovial sarcoma may benefit from contemporary trial designs incorporating more of a risk‐based directed neoadjuvant chemotherapy and RT approach. Higher R0 margin status rates were achieved in protocols with specified preoperative RT, which resulted in improved outcomes.

Kostas Tsourlis, a patient with thalassaemia from Germany, describes the disease as a battle fought from within: a discipline of self-control after a near-fatal lapse in treatment as a teenager. Shaluka Hiran Premachandra, a patient from Sri Lanka, tells a different story: a battle fought from the outside, against geography, health-care systems, and unequal access to care. Different countries, different perspectives, the same disease.

Thalassaemia care is currently undergoing a transformation.1 Transfusion dependence can now be reduced pharmacologically and abolished through gene addition or gene editing. Yet across Asia, patients still die young from inadequate transfusion, iron toxicity, and infection, as a result of fragmented monitoring and follow-up. This Series brings together four complementary papers2–5 examining the epidemiology of thalassaemia in Asia, current approaches to prevention and control, the rapidly evolving therapeutic landscape of β-thalassaemia, and future strategies to improve access to care through scalable therapies, artificial intelligence (AI), and international collaboration.

Thalassaemia syndromes are inherited anaemias characterised by reduced or absent production of globin chains, resulting in impaired haemoglobin synthesis and ineffective erythropoiesis. Clinical manifestations range from asymptomatic carrier states to severe transfusion-dependent anaemia and, in the most severe forms, death in utero. Although scientific interest in β-thalassaemia has progressively increased since the 1990s, with a marked acceleration from the early 2000s onwards, α-thalassaemia has received comparatively less attention despite affecting millions of individuals worldwide and accounting for a substantial burden of fetal loss and chronic anaemia in some regions.

In this issue of The Lancet Haematology, Thomas N Williams and colleagues report on findings from a retrospective cohort study from the Realizing Effectiveness Across Continents with Hydroxyurea (REACH; NCT01966731) trial, an open-label, single-arm trial of hydroxyurea for children with sickle cell anaemia in Angola, DR Congo, Kenya, and Uganda.1 After providing trial hydroxyurea and tracking the incidence of infections for 10 years, they did not find an association between hydroxyurea exposure and increased risk or severity of clinically diagnosed infections.

B-cell maturation antigen (BCMA)-targeting bispecific T-cell engagers (TCEs) have transformed outcomes in relapsed or refractory multiple myeloma. In The Lancet Haematology, Sumit Madan and colleagues1 report a phase 1 study of MK-4002, a novel BCMA-directed TCE built on the TriTAC platform, which simultaneously engages BCMA, CD3, and albumin. Unlike currently approved anti-BCMA TCEs, MK-4002 lacks an Fc domain, a design intended to limit non-specific immune-cell engagement. The results highlight a critical question for the field: with several effective anti-BCMA TCEs already approved, what does any single TCE format offer over another?

We read with great interest the comprehensive registry-based cohort study by Ali Bazarbachi and colleagues,1 which evaluated the temporal trends in post-transplantation outcomes for patients with relapsed or refractory classical Hodgkin lymphoma. The authors show that both 2-year progression-free survival and overall survival after allogeneic hematopoietic cell transplantation (allo-HCT) have significantly improved over the past decade. Although we commend the authors for leveraging the extensive European Society for Blood and Marrow Transplantation database, we wish to raise two crucial methodological considerations—potential confounding by disease status dynamics and the interpretation of interactions between donor type and post-transplantation cyclophosphamide.

We thank Qianpeng Li and colleagues for their thoughtful comments regarding our European Society for Blood and Marrow Transplantation registry-based analysis of transplantation outcomes in relapsed and refractory classical Hodgkin lymphoma.

We appreciated the Personal View paper by S Vincent Rajkumar and Shaji Kumar that was published in The Lancet Haematology1 on redefining primary plasma cell leukaemia as high-risk multiple myeloma and would like to provide some further comments.

Living with thalassaemia major means existing within the corset of an unrelenting biological cadence. My calendar is not dictated by personal desires, but by the frequency of blood transfusions and vital iron chelation therapy, a rhythm I have known since childhood, growing up in Nuremberg, Germany, where I have been treated all my life at the General Hospital of Nuremberg, the city my parents settled in when they migrated from Greece in the late 1950s.

My journey with thalassaemia began in childhood in Sri Lanka, and one of the things I remember most is the difficulty my family experienced in understanding the condition and finding appropriate treatment. From what I have learned from my parents and relatives, they had to visit hospitals across Sri Lanka in search of answers and appropriate care. At that time, awareness and understanding of thalassaemia among doctors and other health-care professionals in Sri Lanka were much more limited than they are today.

In the large REACH cohort, the incidence rate or severity of clinically diagnosed infections in children with sickle cell anaemia living in sub-Saharan Africa, was not increased during the hydroxyurea treatment phases of this trial. Our results provide reassurance that, even when administered at MTD, hydroxyurea does not put children with sickle cell anaemia at increased risk of illness or death from infections.

In a large Erdheim–Chester disease cohort spanning multiple eras, mortality remains substantial. These findings support early identification of patients with high-risk features and development of risk-adapted follow-up and treatment strategies.

The addition of decitabine to BuCy conditioning reduced the risk of relapse with an acceptable safety profile in adult patients with KMT2A‑rearranged leukaemia and could be a suitable therapeutic option for this population.

MK-4002 had manageable safety and clinical activity at doses of 2·15 mg or higher in participants with heavily pretreated relapsed or refractory multiple myeloma. Optimal safety and activity were observed at 12 mg, supporting further clinical evaluation of this dose.

β-thalassaemia is characterised by ineffective erythropoiesis, chronic anaemia, haemolysis, and progressive iron-related and non-iron-related morbidity. Although transfusion, iron chelation, multidisciplinary care, and allogeneic haematopoietic stem-cell transplantation have substantially improved outcomes, major gaps persist in treatment burden, access, safety, adherence, and curative feasibility. Over the past decade, the therapeutic landscape has expanded rapidly, with disease-modifying agents targeting erythroid maturation and red cell metabolism, including luspatercept and mitapivat, now available as options for both transfusion-dependent and non-transfusion-dependent β-thalassaemia.

Advances in the treatment of thalassaemia have led to major improvements in survival and quality of life over the past 30 years. In addition to developments in stem-cell transplantation, transfusion safety, iron overload monitoring, and iron-chelation therapy, novel disease-modifying and gene therapies are also emerging. However, substantial disparities in access to specialised care and novel therapies persist, particularly in low-income and middle-income countries, where most people with thalassaemia reside.

Hereditary haemorrhagic telangiectasia is the second most common heritable bleeding disorder worldwide, with a prevalence more than twice that of haemophilia, and is the most morbid inherited bleeding disorder of women. As an autosomal dominant vasculopathy due to dysregulated angiogenic signalling, patients with hereditary haemorrhagic telangiectasia develop telangiectasias and arteriovenous malformations which cause numerous complications. These complications include moderate-to-severe chronic epistaxis, gastrointestinal bleeding, iron deficiency anemia, and requirement for intravenous iron or red cell transfusion.

A 51-year-old White man with a two year history of transfusion-dependent microcytic anaemia was referred to the haematology clinic at the University of California, Los Angeles (CA, USA) for possible myelodysplastic syndrome with anaemia. An initial exam found bronze skin pigmentation and palpable hepatosplenomegaly. Peripheral blood testing revealed a normal white blood cell count and platelet count, but a haemoglobin concentration of 7·4 g/dL (normal range 13·2–17·1 g/dL) and mean corpuscular volume result of 63·1 fL (normal range 81·4–101·7 fL).

Chimeric antigen receptor (CAR) T cells have transformed treatment of B-cell malignancies, but rare occurrence of CAR transgenic T-cell malignancies raise genomic safety concerns. In this Blood Spotlight, Baumgartner, Dickinson, and Blombery review CAR transgenic T-cell lymphoproliferative neoplasms and propose a multistep model involving preexisting clonal fitness, CAR T-cell manufacturing, vector integration, CAR construct biology, and postinfusion selection, along with practical diagnostic criteria and risk-based genomic surveillance.

Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare, highly aggressive, BCL2-dependent and CD123-expressing myeloid neoplasm that has a poor prognosis after intensive combination chemotherapy. Lane and colleagues report a phase 2 study of triplet therapy with the CD123-directed fusion toxin tagraxofusp, venetoclax, and azacitidine for patients with newly diagnosed or recurrent disease. Their early data indicate promising activity when prior CD123-directed therapy has been used, as well as an 88% complete remission rate in the first-line setting. This regimen can serve as a well-tolerated induction regimen with low treatment-related mortality, which facilitates allogeneic stem cell transplantation as definitive therapy.

Immune thrombocytopenia (ITP) is characterized by impaired immune tolerance and defective regulatory T-cell (Treg) function, but the molecular mechanisms underlying this dysfunction remain poorly understood. Hu and colleagues identified reduced expression of the splicing factor serine/arginine-rich splicing factor 1 (SRSF1) in CD4⁺ naïve T cells as a driver of LCK exon 8 skipping, which weakens T-cell receptor signaling and impairs Treg development in ITP. Their findings uncover an SRSF1-LCK alternative-splicing axis that contributes to immune dysregulation in ITP and may provide a potential biomarker or therapeutic target.

Checkpoint inhibitors have variable effects in T-cell lymphomas and may cause rapid disease progression. In a mouse model of anaplastic large cell lymphoma (ALCL), Poggio and colleagues found that CD4⁺ T cells recruit natural killer cells and increase cytotoxic T-cell activity, with checkpoint inhibition producing complete remission in 50% of mice without rapid progression. Nonresponders had exhausted CD4⁺ T cells with a Th22-like gene expression profile. These findings support clinical testing of checkpoint inhibitors in selected patients with ALCL.

Intestinal dysbiosis is an early event in graft-versus-host disease (GVHD) pathogenesis, and modulation of the gut microbiome is an emerging strategy to maintain intestinal homeostasis and prevent acute gastrointestinal (GI) GVHD. Human milk oligosaccharides (HMO) are unique glycans that structurally resemble intestinal mucus glycans, and they can promote growth of beneficial bacteria in the infant gut. In a phase 1/2 clinical trial with children and young adults undergoing allogeneic transplant, Ramos et al found that the addition of HMO to the diet was well tolerated and associated with substantially lower rates of intestinal dysbiosis, acute GI GVHD, and adenovirus reactivation than contemporary controls.

Refractory primary immune thrombocytopenia (ITP) remains difficult to treat because pathogenic antibody-producing plasma cells and immune memory can persist. Shu et al report that B-cell maturation antigen (BCMA)–directed chimeric antigen receptor (CAR) T-cell therapy rapidly induces complete responses in most patients, with sustained responders showing prolonged suppression of platelet-specific autoantibodies, B-cell depletion, and immune reconstitution accompanied by an acceptable safety profile. These findings provide early proof of concept that targeting plasma cells with CAR T cells can achieve durable remission in refractory ITP, but they require validation in larger prospective studies.

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The final results from the German MINT study evaluating mogamulizumab in patients with mycosis fungoides and Sézary syndrome were recently presented at the European Organisation for Research and Treatment of Cancer Cutaneous Lymphoma Tumour Group (EORTC-CLTG) Annual Meeting 2026 in Berlin, Germany...

On October 16, 2026, the U.S. Food and Drug Administration (FDA) granted traditional approval to pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden–high...

A recent study by researchers from The Univetsity of Texas MD Anderson Cancer Center, ASCO, and collaborating institutions evaluated the national landscape of geographic access to active triple-negative breast cancer clinical trials. The findings—published by Amin et al in Breast Cancer Research...

Among medically underserved adults who smoked and were referred for lung cancer screening, the addition of financial incentives to usual care and free pharmacotherapy significantly increased rates of sustained tobacco abstinence compared with usual care alone or usual care plus free...

The addition of metastasis-directed ablation to first-line systemic therapy did not significantly improve progression-free or overall survival in patients with oligometastatic breast cancer, according to findings from the randomized phase II portion of the NRG-BR002 trial reported by Chmura et al...

I have had many idols in medicine. Many eventually let me down.

Remote expert review of oncology cases may help to address and improve gaps in evidence-based cancer care, while also providing measurable cost savings, according to findings presented in a poster at the 2026 ASCO Quality Care Symposium (Abstract 700). 

A shorter course of postmastectomy radiation therapy was noninferior to conventional radiation therapy in terms of breast reconstruction complications among women with breast cancer undergoing the procedure, according to findings from the randomized RT CHARM trial reported by Poppe et al in the

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Experts Call for Better Quality-of-Life Reporting in Adjuvant Cancer Trials

Clinical trials of adjuvant cancer therapy should do a better job of showing how treatment affects individual patients’ quality of life—particularly when the survival benefit is modest—according to recommendations from Common-Sense Oncology and the European Organisation for Research and Treatment...

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Starting Surveillance Colonoscopy After High-Risk Adenoma Removal: When Is the Right Time?

Surveillance colonoscopy at 5 years after removal of high-risk adenomas was noninferior to surveillance at 3 years in terms of colorectal cancer incidence during the first 5 years after adenoma removal, according to an interim analysis of the randomized EPoS II trial reported by Jover et al in The...

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AI Model Based on Facial Image Analysis Estimates Biological Age and Mortality Risk in Patients With Cancer

Analyzing facial images using a foundational artificial intelligence (AI) model may help researchers determine both biological aging and disease-related mortality risk, according to study findings published in The Lancet Digital Health. 

Tuesday, October 20, 2026 1:30 PM

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Community Oncology Practices Bring Advances in Cancer Testing and Treatment Closer to Patients

Community oncology practices are bringing personalized medicine into everyday cancer care, substantially expanding their use of advanced biomarker testing and novel therapies for patients with metastatic breast cancer and metastatic non–small cell lung cancer, according to new research from...

Tuesday, October 20, 2026 10:55 AM

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FDA Approves Atezolizumab in Combination With Chemotherapy for Stage III dMMR Colon Cancer

On October 8, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients aged 2 years and older with stage III mismatch repair–deficient (dMMR) colon cancer. The FDA...

Friday, October 9, 2026 10:38 AM

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FDA Approves Dostarlimab for MSI-H/dMMR Locally Advanced Rectal Cancer

On October 19, 2026, the U.S. Food and Drug Administration (FDA) granted an accelerated approval to the PD-1 inhibitor dostarlimab (Jemperli) for the treatment of adult patients with stage II/III locally advanced rectal cancer that is microsatellite instability–high (MSI-H) or mismatch repair...

Monday, October 19, 2026 3:00 PM

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National Academy of Medicine Elects 100 New Members for 2026

The National Academy of Medicine (NAM) has announced the election of 90 regular members and 10 international members during its annual meeting. Election to the Academy is considered one of the highest honors in the fields of health and medicine and recognizes individuals who have demonstrated...

Monday, October 19, 2026 3:06 PM

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Phase III VERIFY Trial Demonstrates Benefits of Rusfertide in Polycythemia Vera

According to findings from the phase III VERIFY trial reported by Kuykendall et al in the Journal of Clinical Oncology, the addition of the hepcidin mimetic rusfertide to standard-of-care therapy significantly improved hematocrit control, reduced the need for phlebotomy, and improved...

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ASH Issues New Recommendations for the Management of Myelofibrosis

The American Society of Hematology (ASH) released new guidelines on the management of myelofibrosis which recommend expanded molecular testing, early transplant referral, appropriate use of JAK inhibitors, and aspirin therapy in select patients. The guidelines were published by Stein et al in Blood ...

Monday, October 19, 2026 10:28 AM

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Immunotherapy-Based Downstaging Linked to Improved Outcomes After Liver Transplantation in Hepatocellular Carcinoma

An immune checkpoint inhibitor–based multimodal downstaging strategy before liver transplantation was associated with improved posttransplant survival and a lower risk of recurrence among patients with hepatocellular carcinoma initially beyond the Milan criteria (single lesion not larger than 5 cm...

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Novel Androgen Receptor Degrader Demonstrates Antitumor Activity in Advanced Prostate Cancer

The novel androgen receptor degrader bavdegalutamide demonstrated a manageable safety profile and antitumor activity in patients with metastatic castration–resistant prostate cancer previously treated with androgen receptor pathway inhibitors, particularly those with tumors harboring specific...

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Verifying the Seen and Unseen by AI in Cancer Imaging

Artificial intelligence (AI) can be used in medical imaging and diagnostics to enhance physician capabilities, but also to identify features that humans are not able to see. In research settings, AI has already demonstrated that ability to identify biomarkers from routine medical images and guide...

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AI-Extracted Chart Data for Expanding Surgical Oncology Learnings

Large language models (LLMs) are capable of extracting structured data directly from electronic medical records, expanding data sets available for research, training, and developing artificial intelligence (AI) models.

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Even Highly Curable Childhood Leukemias Take a Substantial Toll on Families, Study Finds

New research published by Rodwin et al in JNCCN—Journal of the National Comprehensive Cancer Network has found that families of children receiving treatment for B-cell acute lymphoblastic leukemia (ALL) experience substantial and lasting challenges beginning early after diagnosis, according to a...

Friday, October 16, 2026 11:04 AM

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Two Studies Show Breast Cancer Survival and Mortality Gaps Are Widening Between Rural and Urban Areas

Survival and mortality disparities for women with breast cancer are widening between rural and urban areas over time, according to findings from two American Cancer Society studies presented at the 2026 ASCO Quality Care Symposium (Abstracts 208 and 253). 

Thursday, October 15, 2026 4:39 PM

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FDA Approves Expanded Indication for Nogapendekin Alfa Inbakicept in BCG-Unresponsive NMIBC

On October 14, 2026, the U.S. Food and Drug Administration (FDA) approved the IL-15 receptor agonist nogapendekin alfa inbakicept-pmln (Anktiva) in combination with bacillus Calmette-Guérin (BCG) for the treatment of adults with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC).

Wednesday, October 14, 2026 12:45 PM

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Iberdomide Triplet Improves MRD-Negative Complete Response in Relapsed/Refractory Multiple Myeloma

Iberdomide combined with daratumumab and dexamethasone nearly doubled the rate of minimal residual disease (MRD)-negative complete response compared with daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma. Lonial et al reported the primary MRD...

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Study Supports Sentinel Lymph Node Biopsy After Chemotherapy in Locally Advanced Breast Cancer

A prospective study found that sentinel lymph node biopsy may be an accurate method of axillary staging in selected patients with locally advanced breast cancer who achieve a clinical nodal response to neoadjuvant chemotherapy—potentially allowing some patients to avoid axillary lymph node...

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.

Three of five National Cancer Institute-sponsored randomized trials that are currently enrolling patients with multiple myeloma have control arms that no longer reflect the standard of care, despite two of these trials being activated in 2026. Comparators in federally sponsored trials need reassessment and, if necessary, updating to reflect changes in clinical practice before and during enrolment.

Patients with intermediate-stage hepatocellular carcinoma typically receive locoregional therapies (LRTs). Nonetheless, most patients receiving LRTs will have disease progression, indicating a need for earlier use of systemic therapies, which were previously reserved for patients with advanced-stage disease. In this Review, the authors describe data from various studies combining LRTs (including transarterial chemoembolization, transarterial radioembolization and external beam radiotherapy) in patients with intermediate-stage hepatocellular carcinoma, as well as discussing the underlying biological rationale for these combinations and the most promising future research directions.

Older adults (aged ≥65 years) comprise the majority of people diagnosed with cancer, yet they remain proportionally underrepresented in cancer research at every stage of the pathway. We call on funders, regulators, researchers and journals to make systematic inclusion of older adults the norm, across studies spanning from cancer prevention to end-of-life care.

The FDA recently approved daraxonrasib for patients with metastatic pancreatic adenocarcinoma who received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. Critics call the second clause non-evidence based. However, this imprecision enables access: trials generally enrol only patients with good performance status, which does not reflect the realities for most patients with metastatic pancreatic adenocarcinoma who never reach second-line therapy because their clinical condition deteriorates first. Real-world evidence should resolve any remaining uncertainty.

Antibody–drug conjugates (ADCs) have transformed the management of various advanced-stage solid cancers. Nonetheless, and despite considerable development efforts, many of these agents lack reliable biomarkers of clinical benefit and/or are reliant on traditional methods of biomarker assessment, with biomarkers of resistance and/or toxicity largely overlooked. In this Review, the authors outline a modular ADC biomarker development strategy that considers the various components of these agents and discuss how biomarkers developed using this strategy might better inform patient selection, therapeutic sequencing, the development of rational combinations, dose optimization and regulatory strategy.

Adjuvant radiotherapy improves outcomes in patients with completely resected atypical meningioma

The iterative development of several highly effective treatments for HER2-positive breast cancer has transformed patient outcomes, but the now-crowded therapeutic landscape raises questions regarding the optimal approach for each patient. In this Review, the authors outline considerations for right-sizing therapy across the disease continuum, and discuss biomarkers that might facilitate this more individualized approach to treatment.

Exercise is widely endorsed as a supportive-care adjunct to mitigate adverse effects of cancer treatment, with data also suggesting potential therapeutic and preventive roles. In this Review, the authors discuss the current evidence from epidemiological studies and clinical trials for exercise as a factor modulating primary cancer risk and disease outcomes after diagnosis, and describe a translational framework for continued development of exercise therapy and a path towards precision exercise oncology.

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Acumen will implement cash-saving strategies and assess its options after sabirnetug failed to beat placebo, leaving the biotech without a clinical program.

Ono Pharma’s ONO-1110 failed five Phase 2 trials, leading to the discontinuation of development in depression and social anxiety. Work will continue for three pain indications.

The disclosure—which came ahead of a presentation of data from the Phase 1 Breakfree-2 study at the ACTRIMS-ECTRIMS meeting—follows Bristol Myers Squibb’s late summer revelation that it had paused certain trials of zolacabtagene autoleucel.

A combination of Tango Therapeutics’ vopimetostat and Revolution Medicines’ recently approved Rasonque led to a response rate of 82% in an ongoing Phase 1/2 trial—a drop from 92% that was reported in June in fewer patients.

After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aardvark plans to resume testing the candidate next year.

Rapport Therapeutics clocked its second Phase 2 win in 14 months for RAP-219—which the company is positioning as a potential pipeline-in-a-product—this time showing improvement in symptoms of bipolar mania.

Gilead’s emvistegrast delivered greater clinical response than placebo, setting up the asset for Phase 3 testing in ulcerative colitis as well as studies in other inflammatory diseases and bolstering the company’s push beyond its HIV portfolio.

AbbVie’s next-gen dual-targeting therapy elicited higher rates of remission than its IL-23 inhibitor Skyrizi in a Phase 2a trial of Crohn’s disease, leading analysts to wonder if the blockbuster can be outdone.

Novartis will continue to study Fabhalta in other indications, with late-stage studies in two rare diseases—atypical haemolytic uraemic syndrome and generalized myasthenia gravis—expected to read out later this year and next year, respectively.

Arrowhead Pharmaceuticals’ siRNA candidate achieved “compelling” tau reductions in an early study of healthy volunteers, with a magnitude of effect that seems to outperformother blood-brain barrier platforms, according to Stifel.

Analysts hailed the Phase 3 head and neck cancer results as a big victory for an asset central to Genmab’s growth plans.

Sac-TMT significantly extended overall and progression-free survival for patients with advanced or recurrent endometrial cancer by 6.9 months over chemotherapy in a Phase 3 trial—becoming the first TROP2-directed ADC to do so in this setting, Merck told BioSpace.

When used alongside AstraZeneca’s Imfinzi, the bispecific T cell engager Imdelltra extended survival by eight months versus Imfinzi alone in Phase 3 study testing the combo in a first-line maintenance setting—a potentially “practice-changing” outcome, according to Truist Securities.

Extending both progression-free and overall survival, Genmab’s Rina-S “sets a high bar for future competition” in a market served by AbbVie, analysts said.

After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aardvark plans to resume testing the candidate next year.

AbbVie is eyeing regulatory filings in 2027 for the skin disease drug lutikizumab after clearing multiple endpoints in a late-stage trial, but the results have disappointed some analysts, raising questions about its commercial prospects.

Brepocitinib is on a roll. After winning approval for an autoimmune skin disease, Roivant Sciences subsidiary Priovant’s drug hit all primary and secondary endpoints in a pair of Phase 3 non-infectious uveitis trials, leading analysts to say the candidate “looked superior to Humira.”

Bracing for patent losses on its cornerstone product Darzalex, Genmab has bet its future on three cancer programs that will deliver pivotal readouts in quick succession.

Disc Medicine’s bitopertin—rejected by the FDA in February—significantly reduced levels of a key disease biomarker and significantly increased the time patients with erythropoietic protoporphyria were able to spend in the sun and artificial light.

In the wake of a successful IPO and strong stock growth throughout the year, Veradermics now has late-stage data to support a regulatory package for its hair loss pill.

Acumen will implement cash-saving strategies and assess its options after sabirnetug failed to beat placebo, leaving the biotech without a clinical program.

Early-stage clinical data from our company and others point to the Wnt/β-catenin pathway as a new avenue for targeting multiple cancer types.

Ono Pharma’s ONO-1110 failed five Phase 2 trials, leading to the discontinuation of development in depression and social anxiety. Work will continue for three pain indications.

In this episode of Denatured, you’ll hear from Jerome Barley, commercial director at Avion Medical and Ryan Klein, vice president, business development, US and APAC at Resolian. We discuss why Australia has become a magnet for early clinical development, and whether its speed, regulatory clarity and tax incentives are pushing it toward a more integrated biotech role.

Analysts hailed the Phase 3 head and neck cancer results as a big victory for an asset central to Genmab’s growth plans.

Merck stole the show at the European Society for Medical Oncology (ESMO) annual conference, with new data on its Moderna-partnered personalized cancer vaccine leaking prior to the presentation and antibody-drug conjugate sac-TMT making a splash in endometrial cancer; Bristol Myers Squibb revealed the death of a patient with multiple sclerosis in an early-stage trial of zola-cel; and pharma is on track to easily surpass last year’s deal count.

Drug developers increasingly have the option of seeking regulatory approval and commercializing a medicine themselves, rather than accepting an early exit offer. Doing so requires a worldwide strategy.

In a Phase 1 study, treatment with Incyte’s KRAS G12D inhibitor in combination with standard-of-care chemotherapy elicited an 89% confirmed objective response rate in patients with a type of pancreatic ductal adenocarcinoma, leading analysts to draw comparisons with Revolution Medicines’ zoldonrasib.

Sac-TMT significantly extended overall and progression-free survival for patients with advanced or recurrent endometrial cancer by 6.9 months over chemotherapy in a Phase 3 trial—becoming the first TROP2-directed ADC to do so in this setting, Merck told BioSpace.

After sitting through the full presentation on the Phase 3 INTerpath-001 trial at the ESMO Congress over the weekend, analysts are more keen on the personalized mRNA cancer vaccine data that last week spurred a stock selloff for both partners.

On October 26, 2026, the Food and Drug Administration (FDA) approved talazoparib (Talzenna, Pfizer Inc.) in combination with enzalutamide for the treatment of adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer with homologous recombination repair (HRR) gene mutations, as detected by an FDA-authorized test.

On October 16, 2026, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥13 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

On October 19, 2026, the Food and Drug Administration granted accelerated approval to dostarlimab (Jemperli, GSK) for adults with Stage II/III locally advanced rectal cancer (LARC) that is microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-authorized test for solid tumors.

On October 14, 2026, the Food and Drug Administration (FDA) approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.) with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This revises the prior indication for adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors to include patients with high-grade papillary-only tumors.

On October 8, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer. The FDA also approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients 12 years of age and older who weigh 40 kg or greater with Stage III dMMR colon cancer.

On October 7, 2026, the Food and Drug Administration approved tucatinib (Tukysa, Seagen Inc., a subsidiary of Pfizer) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment.

On October 2, 2026, the Food and Drug Administration approved pirtobrutinib (Jaypirca, Eli Lilly and Company) for adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion.

On September 24, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with lenvatinib (Lenvima, Eisai Inc.) for adults with advanced renal cell carcinoma with a clear cell component (ccRCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. 

On September 23, 2026, the Food and Drug Administration approved lirafugratinib (Lyrfigtu, Elevar Therapeutics, Inc.), a kinase inhibitor, for the treatment of adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement.

On September 18, 2026, the Food and Drug Administration approved imlunestrant (Inluriyo) in combination with abemaciclib (Verzenio), for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (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. Inluriyo and Verzenio are manufactured by Eli Lilly and Company.

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).