The U.S. Food and Drug Administration on Thursday granted accelerated approval to Rybrevant Faspro for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. The drug, also known as amivantamab and hyaluronidase-lpuj, is not indicated for oropharyngeal squamous cell carcinoma associated with human papillomavirus, or HPV.
Head and neck squamous cell carcinoma, or HNSCC, is an aggressive, life-threatening disease for which there is a high unmet need for effective therapies, the agency said. Approval was based on trial results showing that more than double the percentage of patients responded to the drug compared with 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, according to the FDA.
“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.”
The Accelerated Approval Program allows earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate or intermediate endpoint, the FDA said. Accelerated approval of Rybrevant Faspro was granted based on overall response rate and duration of response. The agency said it is not yet confirmed whether those results will translate into a clinically meaningful benefit in long-term outcomes, and it has required confirmatory studies to verify and describe clinical benefit.
In an open-label, multicenter clinical trial involving 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, according to the FDA. Of the patients 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 and poor outcomes, the agency said.
The prescribing information for use as a single agent includes warnings and precautions for hypersensitivity and administration-related reactions, interstitial lung disease, also called pneumonitis, dermatologic adverse reactions, ocular toxicity, and harm to an unborn baby. The FDA granted Rybrevant Faspro Breakthrough Therapy designation for this indication. The approval was granted to Janssen Biotech, Inc.