NEW YORK – The European Commission (EC) on Monday granted marketing authorization to AbbVie's Elahere (mirvetuximab soravtansine) as a new therapy option for previously treated patients with folate receptor-alpha (FRα)-positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The companion diagnostic to Elahere, Roche's Ventana FOLR1 (FOLR1-2.1) RxDx assay, also garnered a CE mark on Monday. The immunohistochemistry test can be used to gauge ovarian cancer patients' FRα status at diagnosis or at the first sign of resistance to platinum-based chemotherapy to gauge if they are eligible for Elahere. In order to receive the drug, patients' tumors must have high levels of FRα positivity, defined as FRα expression in greater than or equal to 75 percent of tumor cells with an IHC score of 2+.
The EC's approval was based on data from the Phase III MIRASOL trial, in which Elahere reduced the risk of progression or death by 35 percent compared to chemotherapy. The median progression-free survival was 5.62 months in the Elahere arm and 3.98 months in chemo arm. Elahere also demonstrated longer median overall survival compared to chemo in the trial, 16.46 months versus 12.75 months, respectively.
Earlier this year, the US Food and Drug Administration granted full approval to Elahere in this same indication. The drug was initially granted accelerated approval for FRα-positive ovarian cancer in the US in 2022. Elahere was originally developed by ImmunoGen, which was acquired by AbbVie in February in a deal worth $10 billion.