AbbVie receives positive CHMP opinion for mirvetuximab soravtansine

AbbVie announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the marketing authorization of mirvetuximab soravtansine 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. Patients with ovarian cancer are often diagnosed with late-stage disease, undergo surgery and are then primarily treated with platinum-based chemotherapy. Over time patients may become resistant to platinum-based treatment and will require another therapy. The CHMP’s opinion is supported by results of the Phase 3 MIRASOL clinical trial and the European Commission decision on this indication for mirvetuximab soravtansine is anticipated later this year.