AbbVie: CHMP Adopts Positive Opinion For Mirvetuximab Soravtansine - Quick Facts

(RTTNews) - AbbVie (ABBV) announced the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the marketing authorization of mirvetuximab soravtansine, or ELAHERE, for the treatment of adult patients with folate receptor alpha-positive, platinum-resistant and high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior treatment regimens. The European Commission decision on this indication for mirvetuximab soravtansine is anticipated later in the current year.

ELAHERE was granted full FDA approval in March 2024. The CHMP's opinion is supported by results of the Phase 3 MIRASOL clinical trial.

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