The FDA has granted accelerated approval to Rybrevant Faspro for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-based chemotherapy and immunotherapy.
The approval is the first in 10 years for patients with recurrent or metastatic head and neck squamous cell carcinoma who had received prior platinum-based chemotherapy, according to a Nov. 5 news release. Rybrevant Faspro is not indicated for patients with oropharyngeal squamous cell carcinoma associated with HPV.
The FDA based the approval on an open-label, multicenter clinical trial involving 102 patients. Rybrevant Faspro had an overall response rate of 42%. Among patients who responded, 56% had a response lasting six months or longer. Currently approved therapies are associated with an overall response rate of around 20% or less.
The FDA granted Rybrevant Faspro breakthrough therapy designation for this indication. Confirmatory studies are required to verify and describe its clinical benefit. The approval was granted to Janssen Biotech.
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