ImmunoGen Announces Accelerated Approval Pathway for Mirvetuximab Soravtansine in Ovarian Cancer
ImmunoGen, Inc. (IMGN)
Last immunogen, inc. earnings: 5/1 06:30 am
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Source: Business Wire
Top-Line Data from New Pivotal Single-Arm Trial, SORAYA, Expected in First Half of 2021 Confirmatory MIRASOL Trial for Mirvetuximab on Track to Start by Year-EndConference Call to be Held at 8:00 a.m. ET Today WALTHAM, Mass.--(BUSINESS WIRE)--ImmunoGen Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab soravtansine. Based on this guidance, the company will initiate SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with folate receptor alpha (FRa)-high platinum-resistant ovarian cancer who have been previously treated with Avastin® (bevacizumab).“We have engaged in constructive discussions with FDA and evaluated all avenues to bring mirvetuximab to patients more quickly,” said Mark Enyedy, ImmunoGen’s Pres
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