J&J's Rybrevant Faspro wins US FDA accelerated approval for head and neck cancer

What's the deal? On 5 November 2026 the US Food and Drug Administration (FDA) granted accelerated approval to Johnson & Johnson Innovative Medicine's Rybrevant Faspro (amivantamab with hyaluronidase), given as a subcutaneous injection, as a single agent for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose cancer has progressed after platinum-based chemotherapy and an anti-PD-(L)1 immunotherapy. It is the first approval in 10 years of a drug for this patient group, and the first dual-targeted therapy approved in this setting.

Why it matters: HNSCC is an aggressive cancer of the mouth, throat and voice box with limited treatment options once chemotherapy and immunotherapy stop working. The approval is based on an open-label trial of 102 patients in which 42% of patients saw their tumours shrink or disappear, and 56% of responders kept that response for at least six months — more than double the response rate of around 20% or less seen with previously approved therapies. Because it is an accelerated approval, Johnson & Johnson must run confirmatory studies to verify the clinical benefit. The drug is a bispecific antibody that binds two targets at once (EGFR and MET) to block tumour growth signals; it is not indicated for HPV-associated oropharyngeal cancer.

Read more: US FDA, 5 November 2026 · Johnson & Johnson, 5 November 2026