The European Medicines Agency recommends granting marketing authorization to the medicinal product Elahere for the treatment of adults with FR-alpha-positive ovarian, fallopian tube, and primary peritoneal cancer. Elahere contains the active substance mirvetuximab soravtansine, an antibody-drug conjugate that binds to FR-alpha receptors on cancer cells, leading to cell cycle arrest and cell death. The product showed efficacy in improving survival compared to chemotherapy in patients with platinum-resistant cancer. Common side effects include blurred vision, nausea, and fatigue. Elahere should be prescribed by experienced physicians and will be available as a solution for infusion. The product had orphan medicine designation during development, and the European Commission will make a final decision on marketing authorization.
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EMA Backs Approval of Elahere for Ovarian Cancer
