FDA grants full approval for AbbVie’s Elahere

The US Food and Drug Administration (FDA) on Friday approved the supplemental Biologics License application (sBLA) for Elahere (mirvetuximab soravtansine-gyn) submitted by ImmunoGen, which was acquired last year by US pharma major AbbVie (NYSE: ABBV) for $10 billion.

Elahere, an antibody-drug conjugate, is authorized for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Patients are selected based on an FDA-approved test. Mirvetuximab soravtansine-gynx previously received accelerated approval for this indication.

"The full FDA approval of Elahere for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team. Elahere is the first and only antibody-drug conjugate (ADC) approved in the U.S. for this difficult-to-treat malignancy," said Dr Roopal Thakkar, senior vice president, chief medical officer, global therapeutics, AbbVie.