FDA Grants Priority Review of ImmunoGen's Supplemental Biologics License Application for ELAHERE (Mirvetuximab Soravtansine-Gynx) in Platinum-Resistant Ovarian Cancer

Author: Benzinga Newsdesk | December 05, 2023 07:31am

ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the US Food and Drug Administration (FDA) has filed the supplemental Biologics License Application (sBLA) supporting the conversion of the accelerated approval of ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens to full approval. The application has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of April 5, 2024.

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