The Priority Review

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head and neck squamous cell carcinoma

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  1. Approvals

    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.