regulatoryhigh confidence

FDA Grants Accelerated Approval to Subcutaneous Amivantamab (Rybrevant Faspro) for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

|Cancer Breakthroughs

The FDA listed an accelerated approval on November 5, 2026 for amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) in recurrent or metastatic head and neck squamous cell carcinoma. Accelerated approval is contingent on confirmatory trials; trial details were not read beyond the FDA notification listing.

FDA oncology approval notification
FDA oncology approval notification — U.S. FDA