FDA Fully Approves ELAHERE® for Specific Ovarian Cancer Patients

AbbVie (NYSE: ABBV) has announced today that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for treating 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. These patients, commonly diagnosed at advanced stages, typically undergo surgery followed by platinum-based chemotherapy. However, some may develop resistance to this treatment, necessitating alternative therapies like ELAHERE.

“The full FDA approval of ELAHERE for eligible ovarian cancer patients marks the culmination of extensive efforts by the ImmunoGen team. ELAHERE stands as the sole antibody-drug conjugate (ADC) approved in the U.S. for addressing this challenging malignancy,” commented Roopal Thakkar, M.D., Senior Vice President and Chief Medical Officer, Global Therapeutics, AbbVie.

Initially granted FDA accelerated approval in November 2022, ELAHERE has now transitioned to full approval, based on findings from the confirmatory Phase 3 MIRASOL trial. This trial compared ELAHERE with investigator’s choice (IC) chemotherapy in platinum-resistant ovarian cancer (PROC) patients whose tumors exhibit high FRα levels and who have undergone up to three prior therapies. The primary endpoint of MIRASOL was progression-free survival (PFS) by investigator assessment, with key secondary endpoints including objective response rate (ORR) and overall survival (OS).

“As the first treatment to demonstrate a statistically significant overall survival benefit in platinum-resistant ovarian cancer patients, ELAHERE offers a promising new option for individuals with folate receptor alpha positive tumors. Previously, these patients faced very limited choices, and ELAHERE alters that landscape,” remarked Kathleen Moore, Deputy Director and Associate Director of Clinical Research at the Stephenson Cancer Center of The University of Oklahoma and MIRASOL principal investigator.

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