The FDA has granted Alkermes fast-tracked designation for Nemvaleukin Alfa (nemvaleukin) to treat patients with mucosal melanoma, following nemvaleukin’s orphan drug designation earlier in the year. Nemvaleukin alfa is Alkermes’ first investigational engineered interleukin-2 (IL-2) variant immunotherapy for the treatment of mucosal melanoma. Alkermes is currently enrolling for their ARTISTRY-6 study, a global phase 2 trial which will assess the drug’s anti-tumor activity, safety and efficacy in melanoma patients who have already received anti-PD-(L)1 treatment. The FDA’s fast-tracked process enables the accelerated advancement and assessment of possible therapies for severe diseases and unmet medical needs.
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