Alkermes today (3/11) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for its nemvaleukin alfa, an investigational engineered interleukin-2 (IL-2) variant immunotherapy for treatment of mucosal melanoma, a rare type of melanoma that occurs on mucosal surfaces. Orphan Drug Designation is intended to treat conditions or diseases that affect fewer than 200,000 people in the US. Jessicca Rege, Ph.D., Vice President, Head of Oncology at Alkermes, stated, “This orphan drug designation is an important milestone for the nemvaleukin alfa program and underscores nemvaleukin’s potential clinical utility in mucosal melanoma, a particularly aggressive form of melanoma for which treatment options remain limited.”
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