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FDA grants accelerated approval to Rybrevant Faspro for head and neck cancer
The FDA granted accelerated approval to Johnson & Johnson's Rybrevant Faspro for adults with recurrent or metastatic head and neck squamous cell carcinoma after platinum chemotherapy and immunotherapy, the agency said.
- New headline Was: “FDA grants J&J accelerated approval for head and neck cancer treatment”
- Our desk filed its story
The U.S. 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 immunotherapy1.
The agency said the disease is aggressive and that effective therapies remain an unmet need1. Reuters also reported that the FDA granted Johnson & Johnson accelerated approval for a head and neck cancer treatment2.
The FDA said this is the first approval in 10 years of a drug for patients with recurrent or metastatic HNSCC who had received prior platinum-based chemotherapy1. The product is not indicated for oropharyngeal squamous cell carcinoma associated with human papillomavirus1.
Approval rested on overall response rate and duration of response in an open-label, multicenter trial of 102 patients, the FDA said1. The agency reported an overall response rate of 42%, with 56% of those who responded having a response lasting six months or longer1. It said currently approved therapies are associated with overall response rates of around 20% or less1.
Accelerated approval allows earlier marketing of drugs for serious conditions based on surrogate or intermediate endpoints1. The FDA said it has required confirmatory studies because it is not yet confirmed whether the response findings will translate into a clinically meaningful benefit in long-term outcomes1.
Angelo De Claro, M.D., director of the FDA's Oncology Center of Excellence, said the approval "represents a meaningful step forward for patients with head and neck squamous cell carcinoma"1.
Prescribing information includes warnings for hypersensitivity and administration-related reactions, interstitial lung disease and pneumonitis, dermatologic adverse reactions, ocular toxicity, and harm to an unborn baby, the FDA said1. The agency granted Breakthrough Therapy designation for this indication and said the approval went to Janssen Biotech, Inc.1.
Not medical advice.
