FDA Grants Priority Review of ImmunoGen’s Supplemental Biologics License Application for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer
ImmunoGen, Inc. (IMGN)
Last immunogen, inc. earnings: 5/1 06:30 am
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Source: Business Wire
Priority Review Granted with PDUFA Date of April 5, 2024 WALTHAM, Mass.--(BUSINESS WIRE)--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 (FRa)-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."With the FDA’s filing of our sBLA, we are one step closer to securing full approval of ELAHERE in the US and establishing this novel ADC as the standard of care in FRa-positiv
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