Health / Drugs & FDA
FDA grants accelerated approval for head and neck cancer treatment
The approval covers certain adults whose recurrent or metastatic disease progressed after chemotherapy and immunotherapy.
Status: source-checked.
The Food and Drug Administration granted accelerated approval Nov. 5 to Rybrevant Faspro for adults whose recurrent or metastatic head and neck squamous cell carcinoma progressed on or after platinum-based chemotherapy and immunotherapy. The medicine combines amivantamab and hyaluronidase-lpuj, the agency said.
The authorization excludes oropharyngeal squamous cell carcinoma associated with human papillomavirus, or HPV, according to the FDA. The agency described the decision as the first drug approval in 10 years for patients with recurrent or metastatic head and neck squamous cell carcinoma previously treated with platinum-based chemotherapy.
In an open-label trial involving 102 patients, 42% had tumors shrink or disappear, the FDA reported. Among patients who responded, 56% had a response lasting at least six months. These results do not establish a survival benefit.
The accelerated approval pathway allows earlier authorization for serious conditions using measures that may predict clinical benefit. The FDA based this approval on response rate and response duration and said confirmatory studies are required because meaningful long-term benefit has not yet been confirmed.
The prescribing information warns of hypersensitivity and administration-related reactions, lung inflammation, skin and eye problems, and harm to an unborn baby, the FDA said. The agency granted the approval to Janssen Biotech; this account reports the agency’s decision, not an independent assessment of the treatment.
What we know / what we don't
What we know
- FDA reported a 42% overall response rate in a 102-patient open-label trial.
- Confirmatory studies are required.
What we don't know
- Whether the response translates into longer survival has not been confirmed.
- Pricing and availability were not addressed in the release.
The source record