ImmunoGen Says FDA Accepts BLA For Mirvetuximab Soravtansine In Ovarian Cancer

(RTTNews) - ImmunoGen, Inc. (IMGN) announced Monday that the US Food and Drug Administration (FDA) has accepted and filed the Biologics License Application (BLA) for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha (FRa)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments.

The application has been granted Priority Review designation and FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 28, 2022.

The BLA seeks approval of mirvetuximab soravtansine under the FDA's accelerated approval pathway, based on results from the pivotal Phase 3 SORAYA trial.

ImmunoGen continues to enroll patients in the confirmatory MIRASOL trial, which is intended to convert the potential accelerated approval to full approval, and expects to announce top-line data from this study in early 2023.