Posted by Michael Wonder on 06 Dec 2023
FDA grants priority review of ImmunoGen’s supplemental biologics license application for Elahere (mirvetuximab soravtansine-gynx) in platinum-resistant ovarian cancer
5 December 2023 - Priority review granted with PDUFA date of 5 April 2024.
ImmunoGen today announced that the US FDA has filed the supplemental biologics license application supporting the conversion of the accelerated approval of Elahere (mirvetuximab soravtansine-gynx) for the treatment of patients with folate receptor alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens to full approval.
