Johnson & Johnson said the FDA granted Priority Review to a supplemental Biologics License Application for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease progressed after platinum chemotherapy and treatment with a PD-1/PD-L1 inhibitor. The company positioned the update as a move toward a subcutaneous option in a setting with limited post-immunotherapy choices. The application is supported by data from the pivotal OrigAMI-4 trial (NCT06385080), a Phase 1b/2 study evaluating subcutaneous amivantamab after prior platinum and PD-1/PD-L1 therapy. J&J reported an overall response rate of 42%, including complete responses in more than one-third of responders, with responses characterized as rapid, deep and durable. If approved, RYBREVANT FASPRO would target EGFR and MET—two pathways linked to tumor growth and resistance in HNSCC. Priority Review shortens FDA timelines, but the treatment remains investigational until a final decision is issued.