Nov 5 (Reuters) – The US Food and Drug Administration on Thursday granted accelerated approval to Johnson & Johnson’s treatment for patients with an advanced form of head and neck cancer whose disease has worsened after chemotherapy and immunotherapy.
The drug, Rybrevant Faspro, is approved for patients with recurrent or metastatic head and neck squamous cell carcinoma, a hard-to-treat cancer for which effective treatment options remain limited, the FDA said.
The approval is the second FDA clearance for Rybrevant Faspro in the past year, expanding the drug’s reach beyond lung cancer to a second tumor type, J&J said.
The treatment can be administered as a subcutaneous injection in about five minutes and targets the EGFR and MET proteins, which are linked to cancer growth.
The agency said its decision was based on data from a trial of 102 patients in which 42% of those treated with the drug saw their tumors shrink or disappear.
Among patients who responded to the treatment, 56% maintained their response for at least six months, according to the FDA.
The agency said currently available therapies for these patients typically have response rates of about 20% or less.
The FDA’s accelerated approval pathway allows treatments for serious conditions to reach the market based on early evidence that they may provide clinical benefit.
J&J will be required to conduct additional studies to confirm the drug’s benefit.
The treatment is not approved for patients with human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma, the FDA said.
The treatment will compete with established therapies including Merck’s Keytruda and Bristol Myers Squibb’s Opdivo.
Rybrevant Faspro previously received the FDA’s “breakthrough therapy” tag for the indication.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shailesh Kuber)
