Zynyz FDA Approval History
Last updated by Judith Stewart, BPharm on March 23, 2023.
FDA Approved: Yes (First approved March 22, 2023)
Brand name: Zynyz
Generic name: retifanlimab-dlwr
Dosage form: Injection
Company: Incyte Corporation
Treatment for: Merkel Cell Carcinoma
Zynyz (retifanlimab-dlwr) is a programmed death receptor-1 (PD-1)-blocking antibody for the treatment of Merkel cell carcinoma.
- Zynyz is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.
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. - Merkel cell carcinoma (MCC) is a rare and aggressive type of skin cancer that usually appears as a painless, reddish-purple skin nodule on the head, neck and arms in skin exposed to the sun. MCC tends to be a fast growing cancer with a high rate of metastatic disease.
- Zynyz is a programmed death receptor-1 (PD-1)-blocking antibody that works to treat Merkel cell carcinoma by binding to the PD-1 protein on immune T-cells to prevent the interaction with the PD-L1 protein on cancer cells. It removes the "brakes" on the immune system, allowing it to attack cancer cells more effectively.
- Zynyz is administered as an intravenous infusion over 30 minutes every 4 weeks.
- Warnings and precautions associated with Zynyz include immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.
- Common adverse reactions include fatigue, musculoskeletal pain, pruritus, diarrhea, rash, pyrexia, and nausea.
Development timeline for Zynyz
Further information
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