FDA clears Rybrevant Faspro under accelerated review for head and neck cancer

Regulators at the U.S. Food and Drug Administration issued accelerated approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) in adults facing recurrent or metastatic head and neck squamous cell carcinoma after platinum-based chemotherapy and immunotherapy failed them, according to an agency statement dated November 05, 2026.

The clearance went to Janssen Biotech, Inc. Agency officials said it is the first drug approved in 10 years for recurrent or metastatic HNSCC patients previously treated with platinum-based chemotherapy. They described the illness as aggressive and life-threatening, with a high unmet need. The product is not indicated when oropharyngeal squamous cell carcinoma is tied to human papillomavirus (HPV).

Support came from an open-label multicenter clinical trial that enrolled 102 patients with recurrent or metastatic HNSCC. Investigators reported an overall response rate of 42% for Rybrevant Faspro, with tumors shrinking or disappearing among responders. Of those responders, 56% maintained a response for six months or longer. Medicines already on the market typically deliver overall response rates around 20% or less, the FDA said.

The Accelerated Approval Program relied on overall response rate and duration of response. Confirmatory studies remain required to show lasting clinical benefit. Breakthrough Therapy designation was also granted for the indication.

Angelo De Claro, M.D., director of the FDA Oncology Center of Excellence, said patients have long faced thin choices. "This therapy offers patients and their physicians a new option with the potential to make a real difference in people's lives."

Labeling for single-agent use lists warnings covering hypersensitivity and administration-related reactions, interstitial lung disease (ILD)/pneumonitis, dermatologic adverse reactions, ocular toxicity, and harm to an unborn baby.