FDA Grants Accelerated Approval to First New Head and Neck Cancer Option in a Decade
Rybrevant Faspro shrank tumors in 42% of patients in a 102-person trial, though the approval is conditional on confirmatory studies.
The U.S. Food and Drug Administration announced on 5 November 2026 that it has granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), made by Janssen Biotech, for adults with recurrent or metastatic head and neck squamous cell carcinoma whose cancer has kept growing after platinum-based chemotherapy and immunotherapy.
What the trial showed
The approval rests on an open-label, multicenter trial of 102 patients with recurrent or metastatic disease.
- 42% of patients had tumors that shrank or disappeared (the overall response rate).
- 56% of those who responded saw the response last six months or longer.
- The FDA says currently approved therapies for this stage of the disease have a response rate of around 20% or less.
The agency describes it as the first approval in ten years for people with this form of cancer who have already been treated with platinum chemotherapy. It also carries the FDA's Breakthrough Therapy designation.
"Today's approval represents a meaningful step forward," said Angelo De Claro, director of the FDA's Oncology Center of Excellence.
Why it matters
Head and neck cancers affect the mouth, throat and surrounding areas, and options become scarce once standard treatments stop working. A therapy that shrinks tumors in a meaningful share of such patients gives doctors and patients an additional choice.
Important context
Accelerated approval is granted on the strength of an intermediate measure, in this case tumor response and how long it lasts, rather than proof that people live longer or feel better. The FDA has required follow-up studies to confirm clinical benefit, and the announcement does not report survival figures.
The drug is not approved for HPV-associated oropharyngeal cancer. Its label lists serious risks, including hypersensitivity and infusion-related reactions, lung inflammation (interstitial lung disease), skin and eye problems, and harm to an unborn baby. Anyone affected by this cancer should talk with their oncologist about whether the treatment fits their situation.
