The FDA has granted an orphan drug designation to alrizomadlin (APG-115) as a potential therapeutic option for patients with stage IIB-IV melanoma, according to an announcement from Ascentage Pharma, the drug developer.1
Regulatory
FDA Grants Orphan Drug Designation to Cavrotolimod for Merkel Cell Carcinoma
The FDA has granted an orphan drug designation to cavrotolimod (AST-008) for the treatment of patients with Merkel cell carcinoma (MCC), according to an announcement from Exicure, Inc.1
Alkermes Announces FDA Orphan Drug Designation for Nemvaleukin Alfa for Treatment of Mucosal Melanoma
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).
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.