FDA Grants Accelerated Approval for New Head and Neck Cancer Treatment

The FDA has granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This treatment is for patients whose disease has progressed after platinum-based chemotherapy and a PD-1/PD-L1 inhibitor, excluding HPV-associated oropharyngeal HNSCC. This marks the first approval in a decade for this specific patient population, with clinical trials demonstrating a 42% objective response rate.