Drugs

Cogent’s Bezuclastinib Combo Delivers Phase 3 Win

Cogent Biosciences is reporting positive data from a Phase 3 study of its KIT inhibitor bezuclastinib, saying that the drug combined with standard therapy sunitinib significantly extended progression-free survival in patients with imatinib-resistant or intolerant gastrointestinal stromal tumors (GIST). It is the first successful Phase 3 study in the second-line setting in more than 20 years, the company says.

In the global PEAK trial, the bezuclastinib–sunitinib combination achieved a median progression-free survival of 16.5 months, compared with 9.2 months for sunitinib alone, Cogent says. The objective response rate also nearly doubled, from 26% with sunitinib monotherapy to 46% with the combination.

Cogent said it plans to submit an NDA to the FDA for bezuclastinib in GIST in the first half of 2026 and will present full results at a scientific meeting next year.

Additionally, the company says the combination was generally well tolerated, with no new safety signals beyond what is known for sunitinib. The most common Grade 3 or greater adverse events included hypertension, neutropenia, elevated liver enzymes, anemia and diarrhea. ALT/AST elevations were mostly transient and resolved; 1.5% of patients discontinued bezuclastinib due to hepatic labs.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome