Alkermes plc (Nasdaq: ALKS) today announced that nemvaleukin alfa (“nemvaleukin", formerly referred to as ALKS 4230), the company’s investigational engineered interleukin-2 (IL-2) variant immunotherapy, has been granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food and Drug Administration (FDA).
Regulatory
Tebentafusp Named FDA Breakthrough Therapy for Advanced Eye Cancer
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Immunocore‘s tebentafusp (IMCgp100) for HLA-A2 positive, inoperable, or advanced uveal melanoma — a common and difficult-to-treat form of eye cancer — the company announced in a press release.
The Paradoxical Behavior of microRNA-211 in Melanomas and Other Human Cancers
Cancer initiation, progression, and metastasis leverage many regulatory agents, such as signaling molecules, transcription factors, and regulatory RNA molecules.
FDA ‘Fast Tracks’ Toripalimab in Frontline Mucosal Melanoma
The FDA granted a Fast Track designation (FTD) to the humanized PD-1 monoclonal antibody toripalimab for the first-line treatment of patients with mucosal melanoma, announced Junshi Biosciences, in a press release.1