FDA grants accelerated approval for head and neck cancer treatment

The FDA said on Thursday 05 November 2026 that it granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-based chemotherapy and immunotherapy.

The approval applies to HNSCC. The FDA said Rybrevant Faspro is not indicated for patients with oropharyngeal squamous cell carcinoma associated with human papillomavirus.

The agency said approval was based on trial results showing that more than double the percentage of patients responded to the drug compared with currently approved therapies. It was the first approval in 10 years of a drug for patients with recurrent or metastatic HNSCC who had received prior platinum-based chemotherapy.

In an open-label, multicenter clinical trial involving 102 patients with recurrent or metastatic HNSCC, Rybrevant Faspro had an overall response rate of 42%. The agency said this meant tumors decreased in size or disappeared. Among patients who responded, 56% had a response lasting six months or longer. Currently approved therapies are associated with an overall response rate of around 20% or less and poor outcomes.

The FDA said accelerated approval allows drugs treating serious conditions and filling an unmet medical need to be approved earlier based on surrogate or intermediate endpoints. Approval of Rybrevant Faspro was based on overall response rate and duration of response. The agency said it is not yet confirmed whether this will translate into a clinically meaningful benefit in long-term outcomes. The FDA has required confirmatory studies to verify and describe clinical benefit.

The FDA said prescribing information for Rybrevant Faspro as a single agent includes 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. The agency granted Rybrevant Faspro Breakthrough Therapy designation for this indication. Approval was granted to Janssen Biotech, Inc.