FDA grants accelerated approval to Rybrevant Faspro for recurrent or metastatic head and neck cancer
Based on a 42% overall response rate in 102 patients, it is the first approval in 10 years for head and neck squamous cell carcinoma after platinum chemotherapy and immunotherapy; confirmatory studies are required and it is not indicated for HPV-associated oropharyngeal cancer.
Why it matters
Accelerated approval rests on response rate and duration of response, so a survival benefit is not yet shown and the FDA has required confirmatory trials. Among responders, 56% had a response lasting six months or longer, against an overall response rate of around 20% or less for currently approved therapies, according to the agency. Warnings include hypersensitivity and administration-related reactions, interstitial lung disease, dermatologic and ocular toxicity. Janssen Biotech holds the approval, and the drug had Breakthrough Therapy designation. Watch the confirmatory study results.
Key facts
- Approved Nov. 5, 2026 to Janssen Biotech
- Overall response rate 42% in an open-label trial of 102 patients
- 56% of responders had a response lasting six months or longer
- Approved therapies show an overall response rate of about 20% or less
- First approval in 10 years after prior platinum chemotherapy
- Breakthrough Therapy designation; confirmatory studies required