Incyte’s Zynyz Secures FDA Approval for Anal Cancer After Previous Rejection

On May 15, 2025, the FDA approved Incyte’s Zynyz (retifanlimab-dlwr) for the treatment of advanced squamous cell carcinoma of the anal canal (SCAC), both with combination chemotherapy and as a single agent34.

Zynyz is the first and only frontline therapy approved for advanced anal cancer, marking a major milestone after a previous FDA rejection four years ago5.

The approval covers use with carboplatin and paclitaxel as first-line treatment for inoperable SCAC, as well as monotherapy for those who have progressed on or are intolerant to platinum-based chemotherapy23.

The pivotal decision was based on results from the phase 3 POD1UM-303/InterAACT2 trial, which showed a 37% reduction in risk of progression or death and a median progression-free survival of 9.3 months (compared to 7.4 months for placebo plus chemotherapy)2.

Zynyz is a PD-1 inhibitor and represents a new immunotherapy option for patients with advanced anal cancer, a disease with previously limited treatment innovations145.

Sources:

1. https://pharmaphorum.com/news/incytes-pd-1-drug-brings-immunotherapy-anal-cancer

2. https://www.oncnursingnews.com/view/retifanlimab-receives-fda-approval-for-advanced-anal-cancer

3. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma

4. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-fda-approval-zynyzr-retifanlimab-dlwr-making-it

5. https://www.ajmc.com/view/retifanlimab-becomes-first-fda-approved-frontline-treatment-for-advanced-anal-cancer