IMGN - ImmunoGen ovarian cancer therapy undergoes FDA priority review

The clinical-stage biotech, ImmunoGen (NASDAQ:IMGN) announced on Monday that the US Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for its ovarian cancer therapy mirvetuximab soravtansine under priority review. With the BLA, ImmunoGen (IMGN) seeks FDA clearance for the antibody-drug conjugate as a monotherapy for patients with folate receptor alpha (FR?)-high platinum-resistant ovarian cancer who have undergone 1 to 3 systemic treatments previously. The company says it is planning to build the infrastructure immediately for a commercial launch of the medication. “We are moving quickly to build out the commercial and medical infrastructure required for a successful launch and look forward to the prospect of delivering mirvetuximab soravtansine to patients later this year,” Chief Executive Mark Enyedy remarked. The FDA has issued a Prescription Drug User Fee Act (PDUFA) action date of November 28, 2022, for the BLA, which is backed by data from the pivotal Phase 3 SORAYA

For further details see:

ImmunoGen ovarian cancer therapy undergoes FDA priority review