EMA recommends approval of Mirvetuximab Soravtansine for marketing authorization

CAR-T Digest - August 2020

30 Sep 2024: EMA recommends approval of Mirvetuximab Soravtansine for marketing authorization

EMA’s CHMP recommended marketing authorization for Mirvetuximab Soravtansine (Elahere), targeting FRα-positive epithelial ovarian, fallopian tube, and primary peritoneal cancer in adults
Developed by AbbVie Deutschland GmbH, Elahere is a 5 mg/ml infusion with an antibody-drug conjugate, which binds to the FRα receptor on cancer cells and delivers DM4, a microtubule inhibitor, inducing cell death
Clinical trials show Elahere improves progression-free and overall survival compared to chemotherapy in platinum-resistant cancer patients with prior treatments
Common side effects include blurred vision, nausea, diarrhea, fatigue, and peripheral neuropathy
Final European Commission approval is expected within 67 days, and EMA will review its orphan medicine designation status