AbbVie has secured European Commission (EC) approval for Elahere (mirvetuximab soravtansine) for treating adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have undergone one to three prior systemic treatment regimens. This marks the first FRα-directed antibody-drug conjugate approved in the European Union, Iceland, Liechtenstein, Norway, and Northern Ireland, addressing a critical need in ovarian cancer treatment.
Clinical Significance
The approval is supported by data from the pivotal Phase 3 MIRASOL trial. The study demonstrated a significant 35% reduction in the risk of tumor progression or death in patients treated with Elahere compared to investigator's choice chemotherapy. Furthermore, the trial revealed a 33% reduction in the risk of death in the Elahere arm, underscoring its potential to improve survival outcomes in this patient population.
Companion Diagnostic
Alongside Elahere's approval, Roche's VENTANA FOLR1 (FOLR1-2.1) RxDx Assay received CE Mark approval. This companion diagnostic test identifies ovarian cancer patients eligible for Elahere by detecting the FRα biomarker, which is highly expressed in approximately one-third of people living with ovarian cancer.
Addressing Unmet Needs
The approval of Elahere offers a much-needed, clinically meaningful option for patients facing recurrent ovarian cancer. According to Clara Mackay, CEO of the World Ovarian Cancer Coalition, ovarian cancer in Europe is three times more deadly than breast cancer, highlighting the urgent need for innovative treatments. Elahere represents a significant advancement, providing a targeted therapy that can potentially improve both survival and quality of life for these patients.
