FDA Grants Fast Track Designation to Nemvaleukin as Treatment for Ovarian Cancer

The drug previously received approval to treat mucosal melanoma but could be used in combination with pembrolizumab.

The FDA granted Fast Track Designation to nemvaleukin alfa (nemvaleukin; Alkermes), an investigational interleukin-2 variant immunotherapy, for the treatment of platinum-resistant ovarian cancer, according to a statement from Alkermes.

“This Fast Track Designation in platinum-resistant ovarian cancer highlights the potential clinical utility of nemvaleukin in combination with pembrolizumab in this difficult-to-treat disease for which there is no approved immunotherapy, and there remains significant need for new treatment options,” Craig Hopkinson, MD, chief medical officer and executive vice president of research and development at Alkermes, said in the statement.

The FDA previously granted Fast Track Designation and Orphan Drug Designation to nemvaleukin for the treatment of mucosal melanoma, in addition to the new designation.

Nemvaleukin is intended to be used in combination with pembrolizumab, an anti-PD-1 antibody.

Fast Track is designed to facilitate the development and expedite the review of different therapies for treatment of serious conditions and fill unmet medical needs.


Alkermes receives FDA Fast Track Designation for Nemvaleukin Alfa in combination with Pembrolizumab for the treatment of platinum-resistant ovarian cancer. Alkermes. News release. October 25, 2021. Accessed October 25, 2021. https://investor.alkermes.com/news-releases/news-release-details/alkermes-receives-fda-fast-track-designation-nemvaleukin-alfa-0

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