The 2025 Annual Congress of the European Society for Medical Oncology (ESMO) featured a track on tumor-agnostic therapies – the first time such a track has been included at ESMO, or at any major medical oncology meeting. “It’s a milestone,” Vivek Subbiah told the audience at a session on how to accelerate tumor-agnostic drug development. Subbiah is chief of early-phase drug development at the Sarah Cannon Research Institute, chair of ESMO’s inaugural tumor-agnostic drug development track, and the author of a paper, published in Cancer Discovery on Oct. 17, 2025, that urges “a transformative acceleration of tissue-agnostic drug development from today’s 10 approvals to 50 to 100 within 25 years.”

Exelixis plans NDA for zanzalintinib on colorectal cancer data

Much-awaited detailed data from Exelixis Inc.’s phase III Stellar-303 study of zanzalintinib, presented at the European Society for Medical Oncology meeting, showed the third-generation, oral tyrosine kinase inhibitor in combination with Tecentriq (atezolizumab, Roche AG) reduced the risk of death by 20% vs. Stivarga (regorafenib, Bayer AG) in the intent-to-treat population of patients with previously treated non-microsatellite instability-high metastatic colorectal cancer. Those overall survival findings are expected to support an NDA filing later this year, though they appeared to fall somewhat short of investor expectations, with shares of Exelixis (NASDAQ:EXEL) down more than 13% at midday.

Olema slides, despite positive breast cancer data with palazestrant

Despite a recent stock surge, Olema Oncology Inc. shares (NASDAQ:OLMA) had slipped 15% at midday to $7.93 each in the wake of updated and positive phase Ib/II results for palazestrant, the company’s metastatic breast cancer drug. Palazestrant, combined with Kisqali (ribociclib), demonstrated encouraging activity across all dose cohorts and subgroups, the company said, with a median progression-free survival of 15.5 months in the 120-mg palazestrant cohort across all patients. Olema was one of the top performers in the third quarter of 2025 on the BioWorld Cancer Index, with shares notching a 130% increase for the period. The study results were presented Oct. 20 at the European Society for Medical Oncology meeting in Berlin.

US FDA drug approvals reach 160 in 2025, second-highest year on record

The U.S. FDA approved 17 drugs in September 2025, bringing the year-to-date total to 160 approvals for the first three quarters, making it the second-highest total on record for this period. Five new molecular entities were approved in the U.S. in September: Stealth Biotherapeutics Inc.'s Forzinity (elamipretide HCl), Eli Lilly and Co.'s Inluriyo (imlunestrant), Merck & Co. Inc.'s Keytruda Qlex (pembrolizumab and berahyaluronidase alfa), Crinetics Pharmaceuticals Inc.'s Palsonify (paltusotine) and Novartis AG's Rhapsido (remibrutinib).

Chugai licenses Rani’s robotic drug delivery technology in $1B deal

Chugai Pharmaceutical Co. Ltd. and Rani Therapeutics LLC have entered into a collaboration and global license agreement to develop and commercialize an oral product that encompasses Rani’s oral delivery technology, the Ranipill, and Chugai’s rare disease antibody in development. Under terms of the deal, Tokyo-based Chugai will pay Rani $10 million up front, up to $75 million for success-based technology transfer and development milestones, up to $100 million in sales-based milestones, and sales-based royalties. Chugai has the option to extend the license to five additional targets under similar deal terms, which, if fully exercised, could bring the total deal value to more than $1 billion. Rani Therapeutics Holdings’ stock (NASDAQ:RANI) rocketed 249% on the news Oct. 17, closing at $1.64 per share.

Grail's DNA blood test improves early cancer detection sevenfold

Grail LLC has presented data showing that when added to standard screening procedures for breast, cervical, colorectal and lung cancers, its Galleri circulating tumor DNA test led to a sevenfold increase in the number of cancers detected. For about three quarters of the 133 cancers that were detected in the Pathfinder 2 trial, there is no standard test, and more than half of these cancers were picked up at an early stage, when they are likely to be more amenable to treatment. The test is trained to detect around 50 different cancer types. In addition, Galleri could accurately point to where the cancer signal was coming from, guiding subsequent diagnoses. The data were presented at the European Society for Medical Oncology meeting in Berlin on Oct. 17.

Also in the news

AB Science, Abbvie, Agenus, Agios, Aicuris, Artiva, Astrazeneca, Atai, Beckley, C4, Catalym, Celltrion, Chiesi, Chugai, Disc, Eli Lilly, Evaxion, Galapagos, Gilead, Gilgamesh, Hansoh, Helsinn, I-Mab, Insmed, Kiniksa, Kite, Marengo, Novabridge, Novartis, Praxis, Pregene, Prelude, Protalix, Rani, Regeneron, Revolution, Roche, Sanofi, Sensei, Sichuan Kelun, Tolremo, Transcenta, Vectus, Viiv, Xortx