IMGN - ImmunoGen files for US approval of mirvetuximab to treat ovarian cancer

ImmunoGen (NASDAQ:IMGN) submitted an application under the accelerated approval pathway to the U.S. Food and Drug Administration (FDA) for mirvetuximab soravtansine as standalone therapy for patients with folate receptor alpha (FR?)-high platinum-resistant ovarian cancer who have previously received one to three prior systemic treatments. The company said the biologics license application was backed by data a phase 3 trial called SORAYA. Full results were presented from the study earlier this month which followed a stock price fall and a downgrade by RBC Capital Markets. The company noted that FDA has 60 days to determine whether the BLA is complete and acceptable for filing. ImmunoGen (IMGN) has requested priority review of the application and, if granted, the review will be completed within six months of the filing date.

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ImmunoGen files for US approval of mirvetuximab to treat ovarian cancer