RegulatoryOfficial

FDA grants accelerated approval to Rybrevant Faspro for recurrent or metastatic head and neck cancer

🇺🇸 FDA · Thu 05 Nov 2026

Janssen's subcutaneous amivantamab product is cleared for HNSCC after platinum chemotherapy and immunotherapy, based on a 42% response rate in 102 patients, with confirmatory studies required.

The US Food and Drug Administration has granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Eligible patients are those whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. The approval, announced on 5 November 2026, went to Janssen Biotech, Inc.

The product is not indicated for oropharyngeal squamous cell carcinoma associated with human papillomavirus (HPV). The agency says this is the first approval in 10 years of a drug for patients with recurrent or metastatic HNSCC who have previously received platinum-based chemotherapy.

The decision rests on an open-label, multicentre trial in 102 patients. The overall response rate was 42%, and 56% of responders had a response lasting six months or longer. The FDA contrasts this with an overall response rate of around 20% or less for currently approved therapies. The agency also granted Breakthrough Therapy designation for this indication.

Accelerated approval was based on overall response rate and duration of response, which are surrogate or intermediate endpoints. Because it is not yet confirmed that these translate into long-term clinical benefit, the FDA has required confirmatory studies to verify and describe that benefit. Angelo De Claro, director of the FDA's Oncology Center of Excellence, said the approval "represents a meaningful step forward for patients with head and neck squamous cell carcinoma".

When used as a single agent, the prescribing information carries warnings and precautions for hypersensitivity and administration-related reactions, interstitial lung disease (ILD)/pneumonitis, dermatologic adverse reactions, ocular toxicity, and harm to an unborn baby.

What it means for your team

  • Pharmacovigilance teams should note the labelled warnings: hypersensitivity and administration-related reactions, ILD/pneumonitis, dermatologic and ocular toxicity, and embryo-fetal harm, as these are likely focus areas for case review and signal detection.
  • Regulatory affairs teams should track the FDA-required confirmatory studies, since accelerated approval depends on verifying clinical benefit.
  • Medical information and labelling teams should check the indication wording, including the exclusion of HPV-associated oropharyngeal squamous cell carcinoma and the requirement for prior platinum-based chemotherapy and immunotherapy.
  • Market-access and competitive-intelligence teams may wish to note the 42% response rate against roughly 20% or less for existing therapies, as cited by the FDA.

Official source: FDA ↗

Article written by VigiEye from the official source (FDA). AI-assisted; check the source before acting.

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