FDA Grants Fast Track Designation to Nemvaleukin for Mucosal Melanoma


The FDA has previously granted Orphan Drug designation to nemvaleukin for the treatment of mucosal melanoma.

Officials with the FDA have granted Fast Track designation to nemvaleukin (nemvaleukin alfa; Alkermes) an investigational engineered interleukin-2 (IL-2) variant immunotherapy, for the treatment of mucosal melanoma. This follows the beginning of enrollment for the ARTISTRY-6 study, a global phase 2 trial evaluating the antitumor activity, safety, and tolerability of nemvaleukin monotherapy in patients with melanoma who have been previously treated with anti-PD-(L)1 therapy.

Fast Track designation is intended to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill an unmet medical need. Nemvaleukin is an engineered fusion protein composed of modified IL-2 and the high-affinity IL-2 alpha receptor chain, which is designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex.

“Receiving Fast Track designation from the FDA for nemvaleukin for the treatment of mucosal melanoma is an important milestone for the nemvaleukin development program and underscores nemvaleukin's potential clinical utility to address an unmet medical need in this difficult-to-treat tumor type,” said Craig Hopkinson, MD, chief medical officer and executive vice president of research and development at Alkermes, in a prepared statement. “We are committed to advancing this important research in mucosal melanoma, a rare and aggressive form of melanoma for which there are very limited treatment options, particularly for those patients previously treated with checkpoint inhibitors.”

The FDA has previously granted Orphan Drug designation to nemvaleukin for the treatment of mucosal melanoma. ARTISTRY-6, 1 of several ongoing trials evaluating nemvaleukin as a potential immunotherapy for cancer, is an open label, multicenter, cohort study with 110 participants. The trial evaluates intravenously administered nemvaleukin in patients with mucosal melanoma and subcutaneously administered nemvaleukin in patients with advanced cutaneous melanoma.


Alkermes receives FDA Fast Track designation for nemvaleukin alfa for the treatment of mucosal melanoma [news release]. Alkermes; August 2, 2021. Accessed August 3, 2021. https://investor.alkermes.com/news-releases/news-release-details/alkermes-receives-fda-fast-track-designation-nemvaleukin-alfa

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