The Food and Drug Administration has granted accelerated approval to Rybrevant Faspro for certain adults with recurrent or metastatic head and neck squamous cell carcinoma, the agency announced November 5. The indication covers people whose disease progressed on or after platinum-based chemotherapy and immunotherapy.
The drug, amivantamab and hyaluronidase-lpuj, is not indicated for patients with oropharyngeal squamous cell carcinoma associated with human papillomavirus, or HPV, according to FDA.
What the trial measured
FDA says approval was based on overall response rate and duration of response. In an open-label, multicenter trial of 102 patients, 42% had a response, meaning their tumors decreased in size or disappeared. Among those who responded, 56% had a response lasting at least six months.
The agency says currently approved therapies have been associated with overall response rates of around 20% or less. Those descriptions do not establish an individual patient's outcome, and the FDA announcement does not present a direct randomized comparison.
Why approval is accelerated
FDA's accelerated approval program allows earlier approval for drugs addressing serious conditions and unmet medical need using a surrogate or intermediate endpoint. The agency says it is not yet confirmed whether the observed response translates into a clinically meaningful benefit in long-term outcomes. It has required confirmatory studies to verify and describe clinical benefit.
FDA says prescribing information for single-agent use includes warnings and precautions for hypersensitivity and administration-related reactions, interstitial lung disease or pneumonitis, skin reactions, eye toxicity and harm to an unborn baby. The agency granted the approval to Janssen Biotech. Its announcement supplies the limits and safety information summarized here; the full prescribing information and trial report were not independently reviewed for this article.