03:31 PM EDT, 03/22/2024 (MT Newswires) -- AbbVie ( ABBV ) said Friday it got full approval from the US Food and Drug Administration for Elahere, or mirvetuximab soravtansine-gynx, for the treatment of certain ovarian cancer patients.

The health's regulator approval was based on the results of the phase 3 Mirasol trial in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer who have been treated with up to three prior therapies, the company said.

The trial, which enrolled 453 patients, showed a 33% reduction in risk of death in the Elahere group compared with those who received the investigator's choice of chemotherapy, the company said. There was also a 35% reduction in the risk of tumor or cancer progression for those treated with Elahere versus those who received the investigator's choice of chemotherapy, according to a statement.

Elahere also demonstrated fewer grade 3+ adverse events and a lower discontinuation rate due to adverse events compared with the investigator's choice of chemotherapy group, the company said.

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