FDA accelerated approval for ImmunoGen's Elahere

The US Food and Drug Administration (FDA) yesterday granted accelerated approval for ImmunoGen’s (Nasdaq: IMGN) Elahere (mirvetuximab soravtansine-gynx) for adult patients with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

The approval comes two weeks before the expected FDA action date of November 28, and the news pushed US antibody-drug conjugate (ADC) specialist ImmunoGen’s shares up 7.5% by close of trading yesterday and up a further 9.4% to $6.30 pre-market this morning.

Mirvetuximab soravtansine-gynx is a folate receptor alpha directed antibody and microtubule inhibitor conjugate. Patients are selected for therapy based on an FDA-approved test.