FDA grants fast track designation to nemvaleukin alfa for mucosal melanoma
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The FDA granted fast track designation to nemvaleukin alfa for treatment of mucosal melanoma.
Nemvaleukin alfa (Alkermes) is an investigational engineered interleukin-2 variant immunotherapy.
Alkermes began enrollment of the phase 2 ARTISTRY-6 trial to evaluate the anti-tumor activity, safety and tolerability of nemvaleukin alfa monotherapy for patients with melanoma who previously received anti-PD-1/anti-PD-L1 therapy.
Researchers will assess IV nemvaleukin alfa for patients with mucosal melanoma and subcutaneously administered nemvaleukin for patients with advanced cutaneous melanoma.
“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 [this therapy’s] potential clinical utility to address an unmet medical need in this difficult-to-treat tumor type,” Craig Hopkinson, MD, chief medical officer and executive vice president of research and development with Alkermes, said in a company-issued press release. “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 previously granted orphan drug designation to nemvaleukin alfa for treatment of mucosal melanoma.
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