FDA Approves a New Drug for Head and Neck Cancer After Chemotherapy Stops Working

The U.S. Food and Drug Administration granted accelerated approval on Nov. 5, 2026, to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with head and neck squamous cell carcinoma that has come back or spread after platinum-based chemotherapy and immunotherapy. The agency describes that cancer as aggressive and life-threatening, with a high unmet need for effective therapies.

The approval covers people whose cancer has kept growing after both of the standard treatments. The FDA says the drug is the first approved in 10 years for patients with recurrent or metastatic disease who had received platinum-based chemotherapy. It does not cover cancers of the oropharynx, the middle of the throat, that are linked to HPV.

In the open-label trial the agency based its decision on, 102 patients with recurrent or metastatic disease were treated, and 42% saw their tumors shrink or disappear. Of the patients who responded, 56% had a response that lasted six months or longer. The FDA's announcement puts the response rate of currently approved therapies at around 20% or less.

Accelerated approval lets a drug reach patients based on measures taken earlier than survival. In this case, the agency used how many patients responded and how long the responses lasted. Because it is not yet confirmed that those measures translate into a long-term benefit, the FDA has required confirmatory studies to verify the drug's clinical benefit. Angelo De Claro, director of the FDA's Oncology Center of Excellence, called the approval "a meaningful step forward for patients with head and neck squamous cell carcinoma, a disease where treatment options have historically been limited and outcomes remain poor."

The prescribing information for the drug, given on its own, carries warnings for hypersensitivity and administration-related reactions, inflammation of the lungs, skin reactions, eye toxicity and harm to an unborn baby. The FDA granted Rybrevant Faspro Breakthrough Therapy designation for this use, and the approval went to Janssen Biotech, Inc.