JNJ · News · 20261106N

RYBREVANT Head And Neck Expansion

JOHNSON & JOHNSON · 2026-11-06 · Importance 41 · Surprise 60

The FDA granted accelerated approval for Johnson & Johnson’s subcutaneous RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) as a single agent for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The indication covers patients whose disease progressed during or after platinum-based chemotherapy and an anti-PD-(L)1 antibody, excluding HPV-associated oropharyngeal cancer. The OrigAMI-4 trial showed a 42% overall response rate, and the five-minute subcutaneous treatment is described as the first dual-targeted therapy approved for this setting and the first new treatment approval for this patient group in a decade. This is RYBREVANT FASPRO’s first approved indication beyond non-small cell lung cancer; confirmatory trials are underway.

Key facts

• Confirmatory trials for RYBREVANT FASPRO are underway to potentially expand its use. source
• The U.S. FDA granted accelerated approval to RYBREVANT FASPRO as a single-agent treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma. source
• RYBREVANT FASPRO is approved for second-line use in advanced head and neck squamous cell carcinoma. source
• The head and neck cancer approval gives RYBREVANT FASPRO its first indication outside non-small cell lung cancer. source
• The FDA approval is the first approval of a dual-targeted therapy for this setting, with RYBREVANT FASPRO targeting EGFR and MET. source
• The accelerated approval was based on tumor response data from Johnson & Johnson’s Phase 1b/2 OrigAMI-4 trial. source
• RYBREVANT FASPRO demonstrated a 42% overall response rate in the OrigAMI-4 trial. source
• Eligible patients are adults whose recurrent or metastatic head and neck squamous cell carcinoma progressed during or following platinum-based chemotherapy and an anti-PD-(L)1 antibody; the label excludes HPV-associated oropharyngeal squamous cell carcinoma. source