The FDA granted Priority Review to a supplemental biologics license application for Johnson & Johnson’s RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in recurrent or metastatic head and neck squamous cell carcinoma after platinum chemotherapy and treatment with a PD-1 or PD-L1 inhibitor. The company said the submission is supported by the OrigAMI-4 Phase 1b/2 trial. In the OrigAMI-4 data, the monotherapy cohort reported an overall response rate of 42%, including complete responses in more than one-third of responders, with response durability described as rapid and deep in the trial findings presented at ASCO and published in the Journal of Clinical Oncology. Priority Review shortens the review timeline but does not indicate approval, leaving RYBREVANT FASPRO investigational while the FDA assesses the application for this subcutaneous dual-targeted setting.