Johnson & Johnson announces FDA approval of RYBREVANT FASPRO for advanced head and neck cancer
The FDA granted accelerated approval for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) as a single agent for 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. The approval is based on a 42 percent overall response rate (95 percent CI, 32-52 percent) from the Phase 1b/2 OrigAMI-4 trial.
Primary source
Company press release (PR Newswire), November 5, 2026
Johnson & Johnson announces U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as First and Only Dual-Targeted Therapy for Advanced Head and Neck Cancer
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