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ImmunoGen Achieves Full FDA Approval for Elahere in Folate Receptor Alpha-Positive Ovarian Cancer

NEW YORK – The US Food and Drug Administration on Friday granted full approval to ImmunoGen's antibody-drug conjugate Elahere (mirvetuximab soravtansine) as a treatment for folate receptor alpha (FRα)-positive epithelial ovarian, fallopian tube, or primary peritoneal cancer.

As of an acquisition completed in February 2024, ImmunoGen is now an AbbVie subsidiary, making Elahere a part of AbbVie's portfolio.

The conversion to a full approval comes after the FDA granted the drug accelerated approval in 2022. To be eligible for Elahere, patients must have had one to three prior lines of systemic treatment and have FRα-positive cancer as determined by an FDA-approved test. When the FDA granted Elahere accelerated approval two years ago, it simultaneously approved Roche's Ventana FOLR1 (FOLR1-2.1) RxDx Assay as a companion diagnostic to identify patients eligible for the drug.

The FDA granted full approval after reviewing the results of the Phase III confirmatory MIRASOL clinical trial in which 453 patients were randomized to receive either Elahere or investigator's choice of chemotherapy. In Elahere-treated patients, the median overall survival was 16.5 months, versus 12.7 months for those on chemotherapy. The median progression-free survival was 5.6 months and 4.0 months for patients on the Elahere and chemo arms, respectively.