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These highlights do not include all the information needed to use ZYNYZ safely and effectively. See full prescribing information for ZYNYZ. ZYNYZ ® (retifanlimab-dlwr) injection, for intravenous use Initial U.S. Approval: 2023
Medication labelWhy this: Advisory · dailymed-prescription
ZYNYZ, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). ZYNYZ, as a single agent, is indicated for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum‑based chemotherapy. ZYNYZ is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials [see Clinical Studies (14.2)].
- generic_name
- retifanlimab-dlwr
- product_names
- retifanlimab-dlwr
- ndc
- 50881-006, 50881-006-03
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en