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Alkermes Gets Fast Track Designation For Nemvaleukin - Quick Facts

Global Biopharmaceutical company Alkermes plc (ALKS), on Monday, said it has received Fast Track designation from the FDA for nemvaleukin for the treatment of mucosal melanoma. The company noted that this 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. Earlier in the current year, the company received orphan drug designation to nemvaleukin for the treatment of mucosal melanoma.

In April, the company announced the initiation of ARTISTRY-6, a global phase 2 trial evaluating the anti-tumor activity, safety and tolerability of nemvaleukin monotherapy in patients with melanoma who have been previously treated with anti-PD-(L)1 therapy.

Mucosal melanoma is a rare and aggressive form of melanoma for which there are very limited treatment options, particularly for those patients previously treated with checkpoint inhibitors.

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