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The U.S. Food and Drug Administration today granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) 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 an aggressive, life-threatening disease for which there is a high unmet need for effective therapies.
Rybrevant Faspro is not indicated as a treatment for patients with oropharyngeal squamous cell carcinoma that is associated with human papillomavirus (HPV).
Approval was based on trial results showing that more than double the percentage of patients responded to the drug compared to currently approved therapies. This is the first approval in 10 years of a drug for patients with recurrent or metastatic HNSCC who had received prior platinum-based chemotherapy.
“Today’s approval represents a meaningful step forward for patients with head and neck squamous cell carcinoma, a disease where treatment options have historically been limited and outcomes remain poor,” said Angelo De Claro, M.D., director of the FDA’s Oncology Center of Excellence. “This therapy offers patients and their physicians a new option with the potential to make a real difference in people’s lives.”
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