This week, the U.S. Food and Drug Administration (FDA) granted full approval to AbbVie’s (NYSE: ABBV) antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer following up to three prior therapies. This approval marks an upgrade from the 2022 accelerated approval of this first-in-class therapeutic.
The FDA’s decision is supported by data from a Phase III confirmatory study, which demonstrated that Elahere met its primary endpoint of progression-free survival (PFS) as assessed by investigators. The FRα-targeted agent showed a 35% reduction in the risk of disease progression compared to chemotherapy, along with a 33% decrease in the risk of death relative to the control group.
According to AbbVie, Elahere is also currently under regulatory review in various other regions.- Flcube.com
