Incyte (INCY) said that the U.S. Food and Drug Administration has approved Zynyz (retifanlimab-dlwr) for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.
The Biologics License Application 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.
Merkel cell carcinoma 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. It tends to grow quickly and has a high rate of metastatic disease, leading to a poor prognosis.
Zynyz is a humanized monoclonal antibody targeting programmed death receptor-1. It is also being studied in additional tumor types and in combination with other Incyte pipeline compounds.
Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.
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