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The Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa for the treatment of mucosal melanoma.
Nemvaleukin alfa is an investigational, engineered fusion protein consisting of modified interleukin-2 (IL-2) and the high-affinity IL-2 alpha receptor chain. By binding to the intermediate-affinity IL-2 receptor complex, nemvaleukin alfa is expected to selectively expand antitumor activity while avoiding the activation of immunosuppressive cells.
The Company is currently evaluating nemvaleukin alfa in adults with melanoma who have previously received anti-PD-(L)1 therapy in a phase 2 study (ClinicalTrials.gov Identifier: NCT04830124). Nemvaleukin alfa will be administered intravenously in patients with mucosal melanoma and subcutaneously in patients with advanced cutaneous melanoma.
The FDA’s Fast Track designation allows for expedited review of therapies that are meant to treat serious or life-threatening conditions. Generally, the designation is granted to therapies that are expected to have an impact on factors such as survival and daily functioning.
“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 & Development at Alkermes.
Reference
Alkermes receives FDA Fast Track designation for nemvaleukin alfa for the treatment of mucosal melanoma. News release. Alkermes. Accessed August 2, 2021. https://www.prnewswire.com/news-releases/alkermes-receives-fda-fast-track-designation-for-nemvaleukin-alfa-for-the-treatment-of-mucosal-melanoma-301345719.html.
