Incyte BLA for Retifanlimab Turned Down by FDA

FDA has issued Incyte a complete response letter on its BLA for retifanlimab, an intravenous PD-1 inhibitor for treating adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on, or who are intolerant of, platinum-based chemotherapy. The company says FDA determined that additional data are needed to demonstrate retifanlimab‘s clinical benefit.

In June, Members of the Oncologic Drugs Advisory Committee voted 13-4 to recommend that FDA defer regulatory action on Incyte’s retifanlimab, pending more research (see earlier story). Panel members felt that the 14% response rate in the POD1UM-202 study was too low to justify a regulatory decision at this time. No concerns were voiced about the drug’s safety, they said. An FDA briefing paper had raised questions about retifanlimab’s safety and efficacy and asked the committee members to recommend whether it was appropriate to consider approving the drug at this time.