Drugs

Merck Favezelimab/Keytruda Trial Misses Endpoint

Merck says the Phase 3 KEYFORM-007 trial of investigational favezelimab and Keytruda (pembrolizumab) failed to meet its primary endpoint (overall survival (OS)) in patients with previously treated PD-L1 positive microsatellite stable metastatic colorectal cancer. A final pre-specified analysis found that the favezelimab and pembrolizumab fixed-dose combination did not demonstrate an improvement in OS compared to standard of care regorafenib (Bayer’s Stivarga) or trifluridine and tipiracil hydrochloride (Taiho Oncology’s Lonsurf), the company says.

Keytruda is currently FDA-approved for treating patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer as determined by an FDA-approved test.

Favezelimab is Merck’s investigational anti-lymphocyte activation gene-3 (LAG-3) antibody. “LAG-3 is a cell surface immunomodulatory receptor expressed on various immune cells that down-regulates T cell proliferation and activation,” the company says. “Favezelimab aims to restore T cell effector function by preventing LAG-3 from binding to its primary ligand, major histocompatibility complex (MHC) Class II molecules.”

Fixed-dose combination of favezelimab and pembrolizumab is being evaluated across multiple solid tumor types and in patients with relapsed or refractory classical Hodgkin lymphoma, it says.

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