FDA Gives J&J's Rybrevant Faspro Accelerated Approval in Head and Neck Cancer
- The FDA granted accelerated approval to subcutaneous amivantamab (Rybrevant Faspro) for recurrent or metastatic head and neck squamous cell carcinoma that progressed after platinum chemotherapy and a PD-(L)1 antibody; HPV-associated oropharyngeal disease is excluded.
- It rests on a single-arm cohort of the Phase 1b/2 OrigAMI-4 study, with confirmatory trials required; the FDA called it the first new drug for this setting in a decade.
💡 Points Based on public reports
This is the first indication outside lung cancer for the EGFR/MET bispecific, and a single-arm response-rate approval means the Phase 3 OrigAMI-5 first-line study now carries the franchise's credibility. Cetuximab remains the comparator everyone will cite; with no randomized data, the open question is how much of the response translates into survival.