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# Advisors Asked Whether to Delay Incyte Cancer Drug Deliberation
- URL: https://www.fdaweb.com/advisors-asked-whether-to-delay-incyte-cancer-drug-deliberation/
- Published: 2021-06-23T12:00:00.000Z
- Updated: 2026-09-14T17:04:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149602

FDA is asking the Oncology Drugs Advisory Committee whether a regulatory decision on Incyte’s retifanlimab to treat advanced or metastatic squamous carcinoma of the anal canal (SCAC) should be delayed until further clinical trial data are available. An agency [briefing document](https://www.fda.gov/media/150251/download?ref=fdaweb.com) released in advance of a 6/24 committee meeting says the question arises from uncertainties about the drug’s effectiveness and safety as shown in the POD1UM-202 trial.

Committee members are asked to discuss “whether the demonstrated magnitude of effect in overall response rate and duration of response constitutes a clinically meaningful treatment effect in patients with recurrent advanced or metastatic SCAC, particularly in the setting of an inconsistent relationship between low response rate and clinical benefit observed in other trials with immune checkpoint inhibitors and the limitations of the small trial size, which may preclude a conclusion that the results are applicable to the general patient population.”

FDA says retifanlimab is an anti-programmed cell death protein-1 antibody. For the BLA, Incyte submitted the results of a single trial as the primary evidence of the drug’s safety, efficacy, and dosage for the proposed indication and to support a request for accelerated approval.

“Given the relatively small size of POD1UM-202 (94 patients registered) and given the demographics and baseline disease characteristics of trial participants, there is uncertainty regarding how applicable the results are to patients who will receive the drug if approved,” the document says.