Zynyz FDA Approval History
Last updated by Judith Stewart, BPharm on May 20, 2025.
FDA Approved: Yes (First approved March 22, 2023)
Brand name: Zynyz
Generic name: retifanlimab-dlwr
Dosage form: Injection
Company: Incyte Corporation
Treatment for: Anal Cancer, Merkel Cell Carcinoma
Zynyz (retifanlimab-dlwr) is a programmed death receptor-1 (PD-1)-blocking antibody used for the treatment of advanced anal cancer and Merkel cell carcinoma.
- Zynyz is 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).
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. - SCAC is the most common type of anal cancer, and most cases are associated with human papillomavirus (HPV) infection. 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 SCAC and MCC 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 (≥ 20%) when used in combination with carboplatin and paclitaxel in SCAC patients include fatigue, peripheral neuropathy, nausea, alopecia, diarrhea, musculoskeletal pain, constipation, hemorrhage, rash, vomiting, decreased appetite, pruritis, and abdominal pain.
Common adverse reactions (≥ 10%) when used as a single agent:
- in patients with SCAC include fatigue, musculoskeletal pain, diarrhea, non-urinary tract infections, perineal pain, hemorrhage, urinary tract infection, rash, nausea, decreased appetite, constipation, abdominal pain, dyspnea, pyrexia, vomiting, cough, pruritus, hypothyroidism, headache, and decreased weight.
- in patients with MCC include fatigue, musculoskeletal pain, pruritus, diarrhea, rash, pyrexia, and nausea.
Development timeline for Zynyz
Further information
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