Oncology ·
FDA grants accelerated approval to amivantamab for recurrent or metastatic HNSCC
The FDA granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma progressing during or after platinum-based chemotherapy and immunotherapy. Approval was based on an open-label, multicenter trial of 102 patients; confirmatory studies are required to verify clinical benefit.
- Accelerated approval covers previously treated recurrent or metastatic HNSCC.
- Trial response rate was 42% among 102 patients.
- Confirmatory studies are required to verify clinical benefit.
- Not indicated for HPV-associated oropharyngeal cancer.
The FDA granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease progressed on or after platinum-based chemotherapy and immunotherapy. It is not indicated for HPV-associated oropharyngeal squamous cell carcinoma. The approval was based on an open-label, multicenter trial involving 102 patients.
The overall response rate was 42%; among patients who responded, 56% had a response lasting at least six months. The FDA said currently approved therapies are associated with response rates of around 20% or less. The agency granted the drug Breakthrough Therapy designation for this indication.
This is an accelerated approval based on overall response rate and duration of response, and it remains unconfirmed whether these outcomes translate into meaningful long-term clinical benefit. The FDA requires confirmatory studies to verify and describe clinical benefit. Prescribing information warns of hypersensitivity and administration-related reactions, interstitial lung disease/pneumonitis, dermatologic reactions, ocular toxicity, and potential harm to an unborn baby.
In practice
For adults with recurrent or metastatic HNSCC progressing on or after platinum-based chemotherapy and immunotherapy, Rybrevant Faspro is now an FDA-approved option, except for HPV-associated oropharyngeal squamous cell carcinoma. The evidence comes from an open-label, multicenter trial of 102 patients, with a 42% response rate and responses lasting at least six months in 56% of responders. Approval is accelerated and based on response outcomes; confirmatory studies must establish clinical benefit. Prescribing information includes warnings for hypersensitivity, lung, skin and ocular toxicities, and fetal harm.
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U.S. Food and Drug Administration: FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.