The FDA has granted accelerated approval to Rybrevant Faspro for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. 

HNSCC is aggressive and life-threatening, and there is a high unmet need for effective therapies. Approval for this therapy was based on trial results showing that more than double the percentage of patients responded to the drug compared to currently approved therapies.

The FDA has required confirmatory studies for the drug since it was part of the Accelerated Approval Program, meaning it is not yet confirmed whether this will translate into a clinically meaningful benefit in long-term outcomes.

Rybrevant Faspro had an overall response rate of 42%; those patients saw their tumor either decrease in size or disappear. 56% of the patients who had a response had that response for six months or longer. Currently approved therapies are associated with an overall response rate of around 20% or less and poor outcomes.