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FDA Press Releases·

FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma

  • The U.S. FDA granted accelerated approval on November 5, 2026, for Rybrevant Faspro (amivantamab & hyaluronidase-lpuj) to treat adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease progressed after platinum-based chemotherapy & immunotherapy.
  • The drug is not indicated for oropharyngeal squamous cell carcinoma associated with human papillomavirus (HPV).
  • Approval marks the first new treatment in 10 years for patients with recurrent or metastatic HNSCC who have received prior platinum-based chemotherapy.
  • Clinical trial results showed an overall response rate of 42% for Rybrevant Faspro compared to approximately 20% or less for currently approved therapies.
  • Among patients who responded, 56% maintained a response lasting six months or longer.
  • The accelerated approval was based on overall response rate & duration of response, with the FDA requiring confirmatory studies to verify long-term clinical benefits.
  • The prescribing information includes warnings for hypersensitivity, administration-related reactions, interstitial lung disease (ILD)/pneumonitis, dermatologic adverse reactions, ocular toxicity, & potential harm to an unborn baby.
  • The FDA granted Rybrevant Faspro Breakthrough Therapy designation for this indication & the approval was granted to Janssen Biotech, Inc.