Incyte Gets FDA Approval of Zynyz, Triggers Milestone Payment to MacroGenics

By Colin Kellaher

Incyte Corp. said on Wednesday the U.S. Food and Drug Administration granted accelerated approval to Zynyz for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma, a rare and aggressive type of skin cancer.

The Wilmington, Del., biopharmaceutical company said the accelerated green light is based on the tumor-response rate and the duration of response, adding that continued approval may be contingent on verification and description of the clinical benefits in confirmatory trials.

The approval triggers the payment of a $15 million milestone payment from Incyte to another biopharmaceutical company, MacroGenics Inc., which developed Zynyz and licensed it to Incyte as part of a 2017 collaboration.

MacroGenics, based in Rockville, Md., said it remains eligible for up to $320 million in potential additional development and regulatory milestones, along with up to $330 million in potential commercial milestones and royalties on sales of the drug.

Incyte noted that it is studying Zynyz in other tumor types and in combination with other pipeline compounds.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

March 22, 2023 14:04 ET (18:04 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.