The FDA granted Priority Review to Johnson & Johnson’s supplemental biologics license application for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in adults with recurrent or metastatic head and neck squamous cell carcinoma after platinum chemotherapy and PD-1/PD-L1 therapy. The proposed indication targets EGFR and MET and would introduce a subcutaneous dual-target regimen for a setting with limited post-platinum options. Priority Review shortens the regulatory review timeline, but the therapy remains investigational until a final decision. The submission is supported by results from the pivotal OrigAMI-4 trial (NCT06385080). In the monotherapy cohort, investigators reported a 42% overall response rate with complete responses in more than one-third of responding patients, alongside rapid, deep, and durable responses in a heavily pretreated population.