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Alkermes plc (ALKS) on Monday said it received Fast Track designation from the FDA for its invstigational drug, nemvaleukin alfa, in combination with pembrolizumab, for the treatment of platinum-resistant ovarian cancer.


RTTNews | Oct 25, 2021 07:30AM EDT

07:30 Monday, October 25, 2021 (RTTNews.com) - Alkermes plc (ALKS) on Monday said it received Fast Track designation from the FDA for its invstigational drug, nemvaleukin alfa, in combination with pembrolizumab, for the treatment of platinum-resistant ovarian cancer.

"We are excited to initiate our planned ARTISTRY-7 phase 3 trial in platinum-resistant ovarian cancer, as we advance nemvaleukin toward potential registration and seek to help patients living with this disease," said Craig Hopkinson, Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

The company had entered into clinical trial collaboration and supply agreement with Merck for a phase 3 study to evaluate nemvaleukin in combination with Merck's KEYTRUDA in patients with platinum-resistant ovarian cancer.

The FDA had previously granted Fast Track designation and Orphan Drug designation to nemvaleukin for the treatment of mucosal melanoma.

Read the original article on RTTNews ( https://www.rttnews.com/3235088/alkermes-gets-fast-track-status-for-nemvaleukin-alfa-pembrolizumab-combination-in-ovarian-cancer.aspx)

For comments and feedback: contact editorial@rttnews.com

Copyright(c) 2021 RTTNews.com All Rights Reserved






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