FDA Grants Accelerated Approval to RYBREVANT FASPRO for Advanced Head and Neck Squamous Cell Carcinoma

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), a dual-targeted subcutaneous therapy, for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed after platinum-based chemotherapy and anti-PD-(L)1 antibody treatment. This marks the first dual EGFR and MET targeted therapy approved for this cancer type, offering a new treatment option for patients with limited alternatives. The approval is based on objective response rate and duration of response findings from the phase 1b/2 OrigAMI-4 trial, which showed a confirmed overall response rate of 42%.