The U.S. Food and Drug Administration has granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma. The approval applies to patients whose disease has progressed on or after platinum-based chemotherapy and immunotherapy.
This marks the first approval in a decade for a drug targeting this specific patient population. Head and neck squamous cell carcinoma is an aggressive and life-threatening disease. There is a high unmet need for effective therapies in this area, as treatment options have historically been limited and patient outcomes remain poor.
Clinical Trial Results for HNSCC Treatment
The approval was based on data from an open-label, multicenter clinical trial involving 102 patients. The trial results showed that Rybrevant Faspro had an overall response rate of 42%. This means that nearly half of the patients saw their tumors either decrease in size or disappear completely.
Among the patients who responded to the treatment, 56% experienced a response lasting six months or longer. This response rate is more than double that of currently approved therapies, which are associated with overall response rates of around 20% or less.
The Accelerated Approval Program allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need. In this case, the FDA granted approval based on the overall response rate and the duration of response. The agency has required confirmatory studies to verify and describe the clinical benefit in long-term outcomes.
Warnings and Designation
The prescribing information for Rybrevant Faspro includes warnings and precautions for several serious side effects. These include hypersensitivity and administration-related reactions, interstitial lung disease or pneumonitis, dermatologic adverse reactions, ocular toxicity, and potential harm to an unborn baby.
The drug is not indicated for the treatment of patients with oropharyngeal squamous cell carcinoma that is associated with human papillomavirus. The FDA also granted Rybrevant Faspro Breakthrough Therapy designation for this indication.
The approval was granted to Janssen Biotech, Inc. Angelo De Claro, M.D., director of the FDA’s Oncology Center of Excellence, stated that the approval represents a meaningful step forward for patients. He noted that this therapy offers patients and their physicians a new option with the potential to make a real difference in people’s lives.
Source: U.S. FDA
