Welcome to OncLive®’s OncFive!
Every week, we bring you a quick roundup of the 5 top stories from the world of oncology—ranging from pivotal regulatory decisions to key pipeline updates to expert insights on breakthroughs that are moving the needle in cancer care. This resource is designed to keep you informed on the latest updates in the space, in just a matter of minutes.
Here’s what you may have missed this week:
The FDA approved narsoplimab-wuug (Yartemlea) for the treatment of adults and pediatric patients aged 2 years or older with hematopoietic stem cell transplant–associated thrombotic microangiopathy (TA-TMA). The decision was supported by single-arm TA-TMA Study and expanded access program data showing a TMA complete response (CR) rate of 61% in evaluable patients, with consistent responses across adult and pediatric cohorts. Treatment led to improvements in platelet count, lactate dehydrogenase levels, organ function, and transfusion independence, with a 100-day survival rate of approximately 73% from TMA diagnosis. This marks the first FDA-approved therapy for TA-TMA, representing a practice-changing advance in post-transplant supportive care.
A new drug application has been submitted to the FDA seeking approval of bezuclastinib (CGT0486) for use in patients with nonadvanced systemic mastocytosis, based on positive results from the phase 2 SUMMIT trial (NCT05186753). Bezuclastinib significantly improved total symptom score at week 24 compared with placebo and led to higher rates of clinically meaningful symptom reduction. The agent also showcased marked biologic activity, with over 95% of evaluable patients achieving at least a 50% reduction in serum tryptase levels. These data support bezuclastinib as a potential disease-modifying therapy in a population with limited approved options.
China’s National Medical Products Administration approved ipilimumab N01 (IBI310; Tabosun) in combination with sintilimab (Tyvyt) as neoadjuvant therapy for patients with stage IIB to III resectable microsatellite instability–high/mismatch repair–deficient colon cancer. The decision was supported by data from the phase 3 NeoShot study (NCT05890742) demonstrating an 82% pathological CR (pCR) rate with the combination versus surgery alone, without increased surgical risk. Earlier phase 1b results showed significantly higher pCR rates with ipilimumab N01 plus sintilimab vs sintilimab monotherapy. This represents the world’s first approval of a CTLA-4 antibody in the neoadjuvant colon cancer setting.
Japan’s Ministry of Health, Labour and Welfare approved tafasitamab-cxix (Minjuvi) plus rituximab (Rituxan) and lenalidomide (Revlimid) for the treatment of adults with relapsed or refractory follicular lymphoma. The decision was based on findings from the phase 3 inMIND trial (NCT04680052), which showed a significant progression-free survival (PFS) benefit over placebo plus rituximab and lenalidomide, at a median PFS of 22.4 months vs 13.9 months (HR, 0.43). Independent review confirmed durable PFS benefit, with median PFS not reached in the tafasitamab arm. This approval establishes a chemotherapy-free, dual CD19/CD20–targeted option in Japan for relapsed/refractory disease.
In December 2025, the FDA issued multiple oncology approvals, including full approval of pirtobrutinib (Jaypirca) for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma based on findings from BRUIN CLL-321 (NCT04666038) and clearance of lisocabtagene maraleucel (Breyanzi) for relapsed/refractory marginal zone lymphoma based on data from TRANSCEND-FL (NCT04245839). Additional approvals included niraparib plus abiraterone (Akeega) for BRCA2-mutated metastatic castration-sensitive prostate cancer based on findings from AMPLITUDE (NCT04497844) and fam-trastuzumab deruxtecan-nxki (Enhertu) plus pertuzumab (Perjeta) for frontline HER2-positive metastatic breast cancer based on data from DESTINY-Breast09 (NCT04784715). The agency also expanded access to subcutaneous formulations of amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) and mosunetuzumab (Lunsumio VELO), improving treatment convenience without compromising efficacy. Collectively, these decisions reflect continued momentum toward precision oncology, novel drug delivery platforms, and earlier use of targeted and cellular therapies.