FDA Grants Accelerated Approval to RYBREVANT FASPRO for Head and Neck Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), a new subcutaneous formulation, for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This approval is for patients whose disease has progressed after platinum-based chemotherapy and an anti-PD-(L)1 antibody, marking the first dual-targeted agent approved in this setting in a decade.