FDA grants full approval to AbbVie’s ovarian cancer drug ELAHERE

AbbVie (NYSE: ABBV) has achieved a significant milestone in the fight against ovarian cancer with the U.S. Food and Drug Administration (FDA) granting full approval for ELAHERE (mirvetuximab soravtansine-gynx), marking a major advancement for patients suffering from this challenging condition. ELAHERE is designed to treat folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal adult cancer patients who have undergone up to three prior therapies. This full approval follows the accelerated approval ELAHERE received in November 2022 and is a testament to the drug’s efficacy and safety profile, as confirmed by the Phase 3 MIRASOL trial.

Patients with ovarian cancer, particularly those who develop resistance to platinum-based chemotherapy, face limited treatment options. ELAHERE’s approval provides new hope for these patients. The drug is the first and only antibody-drug conjugate (ADC) approved in the U.S. for treating this form of malignancy, emphasizing its unique approach and potential impact on patient care.

The MIRASOL trial played a crucial role in achieving this regulatory milestone. This randomized, double-blind, placebo-controlled Phase 3 study demonstrated that ELAHERE significantly extends progression-free survival (PFS) compared to the investigator’s choice of chemotherapy in patients with high levels of FRα expression. The trial’s results, showcasing a meaningful overall survival benefit and a reduction in the risk of disease progression, underscore ELAHERE’s potential as a transformative treatment for patients with platinum-resistant ovarian cancer.

Adverse effects associated with ELAHERE were generally mild to moderate, indicating a favorable safety profile. The most common adverse reactions included increased liver enzymes, fatigue, blurred vision, and gastrointestinal symptoms, among others. ELAHERE’s mechanism of action involves a folate receptor alpha-binding antibody, a cleavable linker, and the maytansinoid payload DM4, which targets and destroys cancer cells while minimizing impact on healthy tissue.

In addition to the U.S., the Marketing Authorization Application (MAA) for ELAHERE is currently under review by the European Medicines Agency (EMA), with further regulatory submissions ongoing in multiple other countries. This global effort to make ELAHERE available underscores AbbVie‘s commitment to addressing unmet medical needs and improving outcomes for patients with ovarian cancer.