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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.

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I’d recommend the Renault Symbioz because it’s essentially a Captur with the extra space many buyers actually want. It looks almost identical up front, but the longer rear body brings a much more useful 492-litre boot, making it a smart alternative to cars such as the Nissan Qashqai without feeling bulky or expensive.

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I’d recommend the Vauxhall Corsa because it’s a simple, practical small hatchback that looks good and drives well. Easy to handle in town, with a solid, functional interior and sporty exterior touches, it balances comfort and everyday usability. It won’t grab attention like a Mini or Peugeot, but the Corsa is reliable, fuss-free, and affordable – a smart choice for anyone wanting a sensible, stylish small car.

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I’d recommend the BYD Seal U because it packs a lot of SUV into a surprisingly affordable package. It’s roomy, tech-rich – with a huge touchscreen and full-cabin air purification – and feels more premium than its price suggests.

It’s smooth and efficient around town thanks to its plug-in hybrid system that offers a range of up to 50 miles, even if the soft suspension and light steering make it less exciting to drive on a twisty road. For space, kit, and value, the Seal U is worth a look.

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I’d recommend the Tesla Model 3 because it offers long-range electric driving, sleek styling, and a spacious, family-friendly interior at a competitive price. The Long Range model can reach around 436 miles per charge, with a huge 590-litre boot, frunk, and a bright panoramic roof making it practical for everyday life.

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• 344 miles of range
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• Heated steering wheel
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• 18-inch wheels

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*Savings are made up of the maximum dealer discount off RRP – subject to dealership, location and trim. Prices correct at the time of writing.