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# Incyte Accelerated Approval for Skin Cancer Drug
- URL: https://www.fdaweb.com/incyte-accelerated-approval-for-skin-cancer-drug/
- Published: 2023-03-22T12:00:00.000Z
- Updated: 2026-09-14T18:21:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154041

FDA has granted Incyte accelerated approval of its BLA for Zynyz (retifanlimab-dlwr), a monoclonal antibody targeting programmed death receptor-1 (PD-1) for treating adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). Approval was based on tumor response rate and duration of response (DOR), according to the company.

MCC is described by Incyte as a rare and aggressive skin cancer that appears as a single, painless, reddish-purple skin nodule on the head, neck and arms in skin exposed to sunlight. It has a high rate of metastatic disease, and an estimated five-year overall survival rate of 14% in patients in those who present with distant metastatic disease.

The BLA included data from the POD1UM-201 trial, an open-label, multiregional, single-arm study that evaluated Zynyz in adults with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy. “Among chemotherapy-naïve patients (n=65), Zynyz monotherapy resulted in an objective response rate (ORR) of 52%...,” the company says. “Among the responding patients, the duration of response (DOR) ranged from 1.1 to 24.9+ months, and 76% (26/34) experienced a DOR of six months or longer, and 62% (21/34) experienced a DOR of 12 months or longer by landmark analysis.”