ALKS Alkermes PLC

By Chris Wack

Alkermes Plc said the U.S. Food and Drug Administration granted fast track designation to nemvaleukin alfa, the company's investigational interleukin-2 variant immunotherapy, in combination with anti-PD-1 antibody pembrolizumab for the treatment of platinum-resistant ovarian cancer.

The FDA previously granted fast track designation and orphan drug designation to nemvaleukin for the treatment of mucosal melanoma.

Fast Track is an FDA process designed to facilitate the development, and expedite the review, of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives fast track designation is eligible for more frequent communication with the FDA throughout the drug development process and a rolling and/or priority review of its marketing application if relevant criteria are met.

Alkermes shares were up 4% to $31.90 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

October 25, 2021 07:29 ET (11:29 GMT)

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