FDA Fully Approves AbbVie's Elahere For Ovarian Cancer

(RTTNews) - AbbVie (ABBV) said that the U.S. Food and Drug Administration has granted full approval for Elahere (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies.

Patients with the cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy. They may become resistant to the treatment and require another therapy, such as Elahere.

Elahere was first granted FDA accelerated approval in November 2022. The conversion to full approval is based on data from the confirmatory Phase 3 MIRASOL trial that supports the medicine as a potential new standard of care for folate receptor alpha -positive, platinum-resistant ovarian cancer.

The data showed that Elahere treatment resulted in an overall survival benefit and reduced the risk of cancer progression by 35%.

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