ImmunoGen Provides Regulatory Update on Mirvetuximab Soravtansine Monotherapy in Ovarian Cancer
ImmunoGen, Inc. (IMGN)
Last immunogen, inc. earnings: 5/1 06:30 am
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US:NASDAQ Investor Relations:
investor.immunogen.com/investor-relations
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Source: Business Wire
Conference 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 the United States Food and Drug Administration (FDA) has recommended that the Company conduct a new Phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor alpha (FRa)-positive, platinum-resistant ovarian cancer as part of a Type C meeting held this week. ImmunoGen requested the meeting to discuss the results of the Phase 3 FORWARD I trial and a potential path to registration for mirvetuximab monotherapy. The agency advised that, because FORWARD I did not meet its primary endpoint under the pre-specified statistical analysis plan, the data generated assessing the secondary endpoints from the study
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