P&T Committee Changes
March 20, 2023FDA Approves Rezzayo for the Treatment ofCandidemia and Invasive Candidiasis
March 22, 2023FDA Approves Zynyz (retifanlimab-dlwr) for the Treatment of Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC)
Mar. 22, 2023 - Incyte has announced that the (FDA) has approved Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). The Biologics License Application (BLA) for Zynyz for this indication has been granted accelerated approval by the U.S. FDA based on tumor response rate and duration of response (DOR). Continued approval of Zynyz for this indication may be contingent on verification and description of clinical benefit in confirmatory trials.
MCC is a rare and aggressive type of skin cancer that frequently appears as a single, painless, reddish- purple skin nodule on the head, neck and arms in skin exposed to sunlight. MCC tends to grow quickly and has a high rate of metastatic disease, leading to a poor prognosis. The estimated five-year overall survival (OS) rate is 14% in patients with MCC who present with distant metastatic disease. MCC impacts less than 1 per 100,000 people in the U.S., but incidence rates are rapidly rising, especially in adults over the age of 65.