FDA Grants Priority Review to Subcutaneous Amivantamab for Recurrent or Metastatic Head and Neck Cancer

The U.S. Food and Drug Administration (FDA) has granted priority review to the supplemental biologics license application (sBLA) for subcutaneous amivantamab and hyaluronidase-lpuj (Rybrevant Faspro). This designation is for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed following platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. This supports a potential first-in-class subcutaneous EGFR/MET–targeted treatment option for this heavily pretreated patient population.