FDA Grants Fast Track Designation to Nemvaleukin Alfa for Mucosal Melanoma

Source: cancer network, August 2021

Nemvaleukin alfa (Nemvaleukin) has been granted fast-track designation by the FDA for the treatment of patients with mucosal melanoma who have received prior treatment with an anti–PD-L1 therapy, according to a press release from Alkermes.1

Nemvaleukin is an engineered interleukin-2 (IL-2) variant immunotherapy that was previously granted for orphan drug designation for mucosal melanoma.2 Additionally, enrollment has begun for the global phase 2 ARTISTRY-6 (NCT04830124) trial, which will investigate the anti-tumor activity, safety, and tolerability of nemvaleukin alfa in patients with mucosal melanoma that have previously undergone treatment with anti-PD-L1 therapy.