FDA Approves Rybrevant Faspro for Head and Neck Cancer

The FDA announced on November 5, 2026 that it granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma that progressed after treatment with platinum-based chemotherapy and immunotherapy. This is the first drug approval in a decade for patients with recurrent or metastatic HNSCC previously treated with platinum-based chemotherapy, according to the FDA. The approval does not include patients with oropharyngeal squamous cell carcinoma associated with human papillomavirus.

The decision was based on an open-label, multicenter trial including 102 patients with recurrent or metastatic HNSCC. The overall response rate was 42%, meaning tumors shrank or disappeared in that proportion of participants. Among patients who responded, 56% had responses lasting six months or longer. The FDA said currently approved therapies have overall response rates of around 20% or less, so the response rate was more than double that of those therapies.

Because the approval relied on overall response rate and duration of response as surrogate endpoints, the FDA required confirmatory studies to confirm clinical benefit. The agency said it is not yet confirmed whether these endpoints will translate into clinically meaningful long-term outcomes.

“Today’s approval represents 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,” said Angelo De Claro, M.D., who directs the FDA’s Oncology Center of Excellence.

The prescribing information for single-agent use lists warnings and precautions for hypersensitivity reactions, administration-related reactions, interstitial lung disease/pneumonitis, skin reactions, eye toxicity, and fetal harm. The FDA granted Breakthrough Therapy designation for this indication and approved the drug for Janssen Biotech. This gives adults with recurrent or metastatic HNSCC whose disease has progressed after platinum-based chemotherapy and immunotherapy a new treatment option.