FDA Grants Priority Review for Subcutaneous Amivantamab in Head and Neck Squamous Cell Carcinoma

The FDA has granted priority review to subcutaneous amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has progressed after platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. This regulatory decision is supported by data from the phase 1b/2 OrigAMI-4 study, which showed a confirmed 42% overall response rate in a relevant cohort.