INCY - Incyte wins FDA nod for Zynyz to treat rare skin cancer
2023-03-22 14:09:27 ET
- Incyte ( NASDAQ: INCY ) announced Wednesday that the FDA cleared its intravenous PD-1 inhibitor Zynyz under the agency’s accelerated approval program for patients with Merkel cell carcinoma (MCC), a rare form of skin cancer.
- The agency has used results on the tumor response rate and duration of response (DOR) linked to Zynyz from the company’s POD1UM-201 trial in approving the therapy.
- Continuous approval of Zynyz for this indication is subject to favorable results from confirmatory trials.
- Zynyz, also known as retifanlimab-dlwr, is a partnership between Incyte ( INCY ) and MacroGenics ( NASDAQ: MGNX ), which, in a separate release, said that it is on track to receive a $15M milestone payment from Incyte ( INCY ) following the approval.
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Incyte wins FDA nod for Zynyz to treat rare skin cancer