Treats inoperable locally recurrent or metastatic squamous cell carcinoma of the anal…. BLA 761334, held by Incyte Corp. Retifanlimab-Dlwr.
As of Nov 13, 2026, BLA 761334 (Zynyz), held by Incyte Corp, was first approved by FDA on Mar 22, 2023, with 5 approved supplements and 0 published complete response letters.
ZYNYZ is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Squamous Cell Carcinoma of the Anal Canal (SCAC) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 18, 2026 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Mar 30, 2026 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Dec 17, 2025 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| May 15, 2025 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Mar 22, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zynyz500MG/20ML(25MG/ML) · injectable;intravenous | Retifanlimab-Dlwr | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 18, 2026 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Mar 30, 2026 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Dec 17, 2025 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| May 15, 2025 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Apr 22, 2024 | Supplement 2Labeling · Standard review | Approved | |
| Mar 22, 2023 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
