Zynyz™ (retifanlimab-dlwr – Incyte) injection received Accelerated Approval from the U.S. Food and Drug Administration (FDA) on March 22, 2023. The programmed death receptor-1 (PD-1) inhibitor is indicated to treat adults who have Merkel cell carcinoma (MCC) that has spread (metastatic) or has returned after prior therapy. The recommended dose is one intravenous (IV) infusion of 500mg once every four weeks. The launch is planned for early next month, through open access. Although exact pricing has not been announced, Incyte stated that the cost for Zynyz will be similar to other PD-1 inhibitors that are FDA-approved to treat MCC. Its complete prescribing information is here.
At a Glance
- Brand (Generic) Name: Zynyz (retifanlimab-dlwr)
- Manufacturer: Incyte
- Date Approved: March 22, 2023
- Indication: for treatment of adult patients who have metastatic or recurrent locally advanced MCC
- Dosage Forms Available: single-dose vials of 500mg/20mL solution for IV use
- Launch Date: early April 2023
- Estimated Annual Cost: Pricing information is not yet available.
- Specialty Status: Zynyz will be added to Express Scripts’ specialty drug list.
- MCC is a form of cancer that occurs on the skin that is exposed to sunlight. MCC spreads quickly, with about 35% of patients having local or distant metastases at diagnosis. If untreated, its five-year survival rate is only about 15%.
- Believed to affect fewer than 3,500 patients in the U.S., MCC is more prevalent among men, Caucasians, and patients over 50 years old.
- Zynyz blocks PD-1 receptors to boost T-cell activity.
- In the open-label PODIUM-201 clinical trial of 65 patients who had not received chemotherapy (chemo) for MCC, 18% of patients had complete responses and 34% had partial responses. Twenty-one of the responses lasted at least one year.
- Nearly one-quarter of patients experienced serious adverse effects that included arrhythmias, and pneumonitis. Other common side effects were diarrhea, fatigue, fever, itching, muscle pain, nausea, and rash.
- Other PD-1 inhibitors approved to treat MCC are Bavencio® (avelumab), which is infused once every two weeks, and Keytruda® (pembrolizumab), which is infused once every three weeks or six weeks.
- Due to the Accelerated Approval, additional positive results from further clinical testing will be needed before full approval is granted.