FDA Grants Accelerated Approval to Rybrevant Faspro for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) for adult patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has progressed after platinum-based chemotherapy and an anti-PD-1/PD-L1 antibody. This marks the first dual-targeted therapy approved in this setting, offering a new subcutaneous treatment option for patients with limited choices. The approval is based on data from the OrigAMI-4 trial, which showed a 42% overall response rate and 15% complete responses, with 56% of responders having a duration of response longer than six months. The indication excludes patients with HPV-associated oropharyngeal squamous cell carcinoma, and continued approval may depend on a confirmatory trial.