Incyte announces FDA accelerated approval of Zynyz

Incyte announced that the U.S. Food and Drug Administration has approved Zynyz, a humanized monoclonal antibody targeting programmed death receptor-1, for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma, or MCC. The Biologics License Application, or BLA, for Zynyz for this indication has been approved under accelerated approval by the U.S. FDA based on tumor response rate and duration of response, or DOR, the company noted. "Continued approval of Zynyz for this indication may be contingent on verification and description of clinical benefit in confirmatory trials," Incyte said. "Zynyz offers patients and healthcare professionals an additional first-line anti-PD-1 option for patients with metastatic or recurrent locally advanced MCC, which can be a challenging and aggressive disease to treat. Incyte is grateful to the investigators and patients around the world who participated in the POD1UM-201 trial. We continue to study the potential of Zynyz in additional tumor types and in combination with other Incyte pipeline compounds," said Herve Hoppenot, Chief Executive Officer, Incyte.