The US Food and Drug Administration (FDA) has granted accelerated approval to Zynyz (retifanlimab-dlwr) for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
The accelerated approval of retifanlimab, a PD-1 inhibitor, was based on response data from the phase 2 PODIUM-201 trial. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
PODIUM-201 (ClinicalTrials.gov Identifier: NCT03599713) included 65 patients with metastatic or recurrent locally advanced MCC who did not receive prior systemic therapy for advanced disease. Patients received retifanlimab at 500 mg intravenously every 4 weeks for up to 24 months or until disease progression or unacceptable toxicity.
The overall response rate was 52%, with 12 patients achieving a complete response and 22 patients achieving a partial response. Twenty-six patients had a response lasting at least 6 months, and 21 had a response lasting at least 12 months.
The most common adverse reactions were fatigue, musculoskeletal pain, pruritus, diarrhea, rash, pyrexia, and nausea. The most frequent serious adverse reactions were fatigue, arrhythmia, and pneumonitis.
Zynyz is supplied as a solution in a single-dose vial (500 mg/20 mL). Treatment is administered as an intravenous infusion after dilution.
The product is expected to be available by early April, according to an Incyte spokesperson.
Incyte announces FDA approval of Zynyz™ (retifanlimab-dlwr) for the treatment of metastatic or recurrent locally advanced merkel cell carcinoma (MCC). News release. Incyte. Accessed March 22, 2023.
Package insert. Incyte; 2023. Accessed March 22, 2023. https://www.zynyz.com/pdf/prescribing-information.pdf
This article originally appeared on MPR