FDA grants accelerated approval to Rybrevant Faspro in head and neck cancer

The US Food and Drug Administration on Thursday granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) 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 approval, granted to Janssen Biotech, excludes HPV-associated oropharyngeal cancer, and the drug had received Breakthrough Therapy designation for this use.

In the open-label trial of 102 patients behind the decision, 42 percent of patients saw their tumors shrink or disappear, and 56 percent of those responses lasted six months or longer, against response rates of around 20 percent or less for currently approved therapies. The approval rests on response rate and duration, so the FDA has required confirmatory studies to verify clinical benefit.