Drugs

Rybrevant Faspro OK’d in Aggressive Head and Neck Cancer

FDA has granted Janssen Biotech accelerated approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) and its use in treating adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. “HNSCC is an aggressive, life-threatening disease for which there is a high unmet need for effective therapies,” an agency release says.

Approval was based on data showing that more than double the percentage of patients responded to the drug compared to currently approved therapies, it says, adding that this is the first approval in 10 years for this patient population.

FDA says that in an open-label trial involving 102 patients with recurrent or metastatic HNSCC, Rybrevant Faspro had an overall response rate of 42%, “meaning these patients saw their tumor either decrease in size or disappear. Of those patients who had a response, 56% had a response lasting six months or longer. Currently approved therapies are associated with an overall response rate of around 20% or less and poor outcomes.”

Merck's Efinopegdutide Shows MASH Resolution, Fibrosis Improvement

Merck's investigational GLP-1/glucagon receptor dual agonist efinopegdutide (MK-6024) demonstrated higher rates of MASH resolution and liver fibrosis improvement than placebo in a Phase 2b trial involving patients with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced fibrosis. The results, presented at the American Association

FDA Clarifies Drug Interaction Study Requirements, Labeling Expectations

FDA officials say drug manufacturers may be able to establish dosing recommendations and characterize drug-drug interaction risks without conducting additional clinical studies, including through pharmacokinetic modeling and real-world data, provided the evidence is scientifically justified. During a series of FDA presentations released 11/4 on [Drug Interaction Information

Significantly More Unannounced Foreign Inspections

FDA associate commissioner for inspections and investigations Elizabeth Miller says unannounced drug inspections in China and India increased significantly in FY 2026 compared with FY 2025 inspection numbers. As reported by the Regulatory Affairs Professional Society’s online Regulatory Focus newsletter, she spoke at the Association for Accessible Medicines’ GRx+

Improve Evaluation of REMS Programs: Study

Yale School of Medicine researchers say there are steps FDA could take to improve the evaluation of elements in Risk Evaluation and Mitigation Strategies (REMS) programs. Writing in JAMA Internal Medicine, the researchers say REMS requirements intended to increase patient and prescriber knowledge of medication safety and risks include medication

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Merck's Efinopegdutide Shows MASH Resolution, Fibrosis Improvement

FDA Clarifies Drug Interaction Study Requirements, Labeling Expectations

Significantly More Unannounced Foreign Inspections

Improve Evaluation of REMS Programs: Study