The FDA has 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 whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. The approval was granted to Janssen Biotech, Inc., which markets the drug.
Rybrevant Faspro is not indicated for patients with oropharyngeal squamous cell carcinoma associated with human papillomavirus. It is the first approval in 10 years of a drug for patients with recurrent or metastatic HNSCC who had received prior platinum-based chemotherapy.
Approval was based on overall response rate and duration of response. In an open-label, multicenter trial of 102 patients with recurrent or metastatic HNSCC, Rybrevant Faspro had an overall response rate of 42%, meaning those patients saw their tumor decrease in size or disappear. Of those who had a response, 56% had a response lasting six months or longer. Currently approved therapies are associated with an overall response rate of around 20% or less.
Because it is not yet confirmed whether the results will translate into a clinically meaningful benefit in long-term outcomes, the FDA has required confirmatory studies to verify and describe clinical benefit.
The prescribing information includes warnings and precautions for hypersensitivity and administration-related reactions, interstitial lung disease/pneumonitis, dermatologic adverse reactions, ocular toxicity, and harm to an unborn baby.
The FDA granted Rybrevant Faspro Breakthrough Therapy designation for this indication. Angelo De Claro, director of the FDA's Oncology Center of Excellence, said the approval offers patients and their physicians a new option in a disease where treatment options have historically been limited and outcomes remain poor.
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