European Medicines Agency acceptance of MAA for mirvetuximab soravtansine (Elahere) in platinum-resistant ovarian cancer.- ImmunoGen, Inc.
ImmunoGen, Inc. announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for mirvetuximab soravtansine (Elahere) for the treatment of patients with folate receptor alpha (FR alpha)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The MAA is supported by positive data from the Phase III MIRASOL trial of Elahere in platinum-resistant ovarian cancer, which was disclosed in May 2023 and subsequently presented as a late-breaking abstract at the 2023 American Society of Clinical Oncology Annual Meeting. In the MIRASOL trial, Elahere demonstrated statistically significant and clinically meaningful improvements in progression-free survival, objective response rate, and overall survival compared to investigator's choice (IC) of single-agent chemotherapy. Elahere demonstrated a tolerable safety profile compared to IC chemotherapy consisting predominantly of low-grade ocular and gastrointestinal events. Elahere was approved by the FDA in November 2022.
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