> ## 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.

# FDA OKs Incyte’s Zynyz for Anal Cancer
- URL: https://www.fdaweb.com/fda-oks-incytes-zynyz-for-anal-cancer/
- Published: 2025-05-15T12:00:00.000Z
- Updated: 2026-09-14T15:11:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159194

FDA has approved an Incyte supplemental BLA for Zynyz (retifanlimab-dlwr) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). In addition, the agency approved Zynyz as a single agent for treating adult patients with locally recurrent or with metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy.

Approval was based on data from two trials — the Phase 3 POD1UM-303/InterAACT2 trial and the Phase 2 POD1UM-202 trial. Results from POD1UM-303/InterAACT2 trial showed a “clinically meaningful and statistically significant 37% reduction in the risk of progression or death,” the company says. “Patients in the Zynyz and chemotherapy combination group achieved a median progression-free survival (PFS) of 9.3 months compared to 7.4 months for patients in the placebo combination group.” The POD1UM-202 study demonstrated that treatment with Zynyz monotherapy produced an objective response rate of 14% and disease control rate of 49%, it adds.