FDA grants accelerated approval to Rybrevant Faspro for advanced head and neck cancer

U.S. regulators have given Johnson & Johnson accelerated approval for Rybrevant Faspro as a single agent in adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. It is the drug's first approved use outside non-small cell lung cancer and the first approval in about a decade for this patient group after platinum chemotherapy. The decision rests on a single-arm cohort in which 42% of 102 evaluable patients responded, but continued approval depends on confirmatory results from the ongoing Phase 3 OrigAMI-5 trial. The label excludes HPV-associated oropharyngeal squamous cell carcinoma.

1. FDA granted accelerated approval to Rybrevant Faspro as a single agent for recurrent or metastatic head and neck squamous cell carcinoma, per a Benzinga report dated 2026-11-06.
2. Eligible patients progressed during or after platinum-based chemotherapy and an anti-PD-(L)1 antibody; HPV-associated oropharyngeal cancer is excluded.
3. Based on Cohort 1 of the Phase 1b/2 OrigAMI-4 trial: 42% confirmed overall response rate among 102 evaluable participants.
4. Complete responses in 15% of patients; partial responses in 28%; 56% of responders kept their response beyond six months.
5. Continued approval is contingent on clinical verification in the Phase 3 OrigAMI-5 trial.
6. The FDA had granted Breakthrough Therapy Designation in February 2026 and Priority Review in July 2026.
7. Per the same report, JNJ shares were about $272.99 at the time of publication, near a 52-week high of $282.01.