Immunogen: Priority Review for Application in Platinum-Resistant Ovarian Cancer

 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.

https://www.biospace.com/article/releases/fda-grants-priority-review-of-immunogen-s-supplemental-biologics-license-application-for-elahere-mirvetuximab-soravtansine-gynx-in-platinum-resistant-ovarian-cancer/