> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Incyte BLA for Retifanlimab Turned Down by FDA
- URL: https://www.fdaweb.com/incyte-bla-for-retifanlimab-turned-down-by-fda/
- Published: 2021-07-26T12:00:00.000Z
- Updated: 2026-09-14T17:07:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149788

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](https://www.fdaweb.com/odac-recommends-deferring-action-on-retifanlimab/)). 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](https://www.fdaweb.com/advisors-asked-whether-to-delay-incyte-cancer-drug-deliberation/) 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.