EMA Backs Approval of Elahere for Ovarian Cancer

The European Medicines Agency (EMA) has determined that the medicinal product Elahere (mirvetuximab soravtansine, AbbVie Deutschland), indicated for the treatment of adults with folate receptor alpha (FR-alpha)–positive epithelial ovarian, fallopian tube, and primary peritoneal cancer, should be granted a marketing authorization.
The active substance of Elahere, mirvetuximab soravtansine, is an antineoplastic monoclonal antibody-drug conjugate.
Mirvetuximab contains an antibody that binds to the FR-alpha receptor, which is expressed on the surface of ovarian cancer cells. The antibody is attached to the microtubule inhibitor, DM4, via a cleavable linker. Upon binding to FR-alpha, mirvetuximab soravtansine is internalized, leading to the intracellular release of DM4 by proteolytic cleavage. Inside the cells, DM4 disrupts the microtubule network, resulting in cell cycle arrest and apoptotic cell death.
Improved Survival
At its monthly meeting on September 19, the EMA’s Committee for Medicinal Products for Human Use (CHMP) reached a consensus that Elahere demonstrated efficacy in improving progression-free survival and overall survival in patients with FR-alpha–positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, compared with chemotherapy (either paclitaxel, pegylated liposomal doxorubicin, or topotecan).
The most commonly reported adverse effects of the treatment were blurred vision, nausea, diarrhea, fatigue, abdominal pain, keratopathy, dry eye, constipation, vomiting, decreased appetite, peripheral neuropathy, headache, asthenia, increased aspartate aminotransferase, and arthralgia.
The CHMP stipulated that Elahere should be prescribed and supervised by physicians experienced in the use of cancer treatments.
The medicinal product will be available as 5-mg/mL concentrate for solution for infusion.
Elahere was designated as an orphan medicine during development, and the EMA said it would review the latest information to determine whether that status should be maintained. 
A final decision on whether to grant a marketing authorization will be taken by the European Commission.
 
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