Medscape March 25, 2024
The US Food and Drug Administration granted full approval to mirvetuximab soravtansine-gynx (Elahere) for adults with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
AbbVie noted in a press release that its antibody-drug conjugate is the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer. It could become a “new standard of care for folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer (PROC),” the company said.
Mirvetuximab soravtansine was previously granted accelerated approval for the indication in November 2022.
The decision to grant full approval was made after reviewing the results of the MIRASOL study, which included 453...
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