Johnson & Johnson’s RYBREVANT FASPRO Receives FDA Priority Review for Advanced Head and Neck Cancer
Johnson & Johnson announced that the U.S. FDA granted Priority Review to its supplemental Biologics License Application for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) as a potential treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease has progressed after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. The subcutaneous therapy targets both EGFR and MET, two pathways associated with tumor growth and treatment resistance, and could become a first-in-class treatment for this setting. The application is supported by the Phase 1b/2 OrigAMI-4 study, in which 42% of patients responded to treatment, with more than one-third of responders achieving a complete response; Priority Review is expected to shorten the FDA review timeline to approximately six months.