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AbbVie’s ELAHERE® Approved in the EU for Platinum-Resistant Ovarian Cancer

NextEdge Admin

19 Nov 2024

2 min 23 sec

AbbVie announced the European Commission (EC) has approved **ELAHERE® (mirvetuximab soravtansine)** for adult patients with folate receptor-alpha (FRα)-positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This marks the first folate receptor alpha-directed antibody-drug conjugate (ADC) approved in the EU, Iceland, Liechtenstein, Norway, and Northern Ireland.

**ELAHERE** offers a new targeted treatment option for a condition where limited therapies have been available for over a decade. "It’s a significant breakthrough for oncologists treating platinum-resistant ovarian cancer,” said Professor Toon Van Gorp of the University of Leuven.

Ovarian cancer is a leading cause of gynecological cancer-related deaths, often diagnosed at late stages. Many patients eventually develop platinum-resistant disease, where treatment options can severely impact quality of life. About one-third of ovarian cancers exhibit high FRα expression, and patient eligibility can be determined using Roche's **VENTANA® FOLR1 RxDx Assay**.

Approval was based on the **Phase 3 MIRASOL trial**, which showed **ELAHERE** significantly reduced the risk of tumor progression or death by 35% compared to chemotherapy (PFS HR: 0.65; p<0.0001) and improved overall survival by 33% (OS HR: 0.67; p=0.0046). Common side effects included blurred vision, nausea, fatigue, keratopathy, and pneumonitis.

“ELAHERE provides hope for patients with recurrent ovarian cancer,” said AbbVie's Chief Scientific Officer, Dr. Roopal Thakkar. This milestone adds a meaningful option for improving survival and quality of life in women facing this challenging disease. Findings were also published in the *New England Journal of Medicine*.