【FDA Approval Alert】Incyte’s retifanlimab-dlwr (Zynyz) Approved for Squamous Cell Carcinoma of the Anal Canal (May 15, 2025)
On May 15, 2025, the U.S. FDA approved retifanlimab-dlwr (Zynyz) for adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). Approval covers both first-line use with carboplatin and paclitaxel and single-agent use after progression on platinum-based chemotherapy. The approval is based on POD1UM-303 (NCT04472429) and POD1UM-202 (NCT03597295).
Disease Overview: Squamous Cell Carcinoma of the Anal Canal (SCAC)
SCAC is a rare malignancy of the anal region. In advanced cases with local recurrence or metastasis, chemotherapy and immunotherapy are considered standard treatment options.
Treatment Summary
- Drug Name: retifanlimab-dlwr (Zynyz)
- Company: Incyte Corporation
- Approval Date: May 15, 2025
- Indications:
- In combination with carboplatin and paclitaxel (first-line)
- As monotherapy after platinum-based chemotherapy
- Mechanism of Action: Anti-PD-1 antibody (immune checkpoint inhibition)
- Pivotal Trials: POD1UM-303 (NCT04472429), POD1UM-202 (NCT03597295)
- Key Efficacy:
- First-line: Median PFS 9.3 vs 7.4 months (HR 0.63; p=0.0006)
- Post-platinum: ORR 14%, median DOR 9.5 months
Patient-Friendly Summary
Zynyz enhances the immune system’s ability to fight cancer, providing a new treatment option for patients with recurrent or advanced anal cancer.
M&A Information
- Subsidiary: Not applicable (Incyte in-house development)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Information: Public Investors (NASDAQ: INCY)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
