On 18 November 2024, AbbVie announced that European Commission (EC) has approved Elahere® (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. According to AbbVie, this makes Elahere® the first and only FRα-directed antibody drug conjugate medicine approved in the EU, as well as Iceland, Liechtenstein, Norway, and Northern Ireland.
The approval is supported by data from the Phase 3 MIRASOL trial which demonstrated a 35% reduction in the risk of tumour progression or death in patients treated with Elahere® compared with chemotherapy, which represented an improvement in progression-free survival.
This news follows the adoption of a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in September 2024. Elahere® was approved by the US FDA in March 2024.