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Elahere FDA Approval History

Last updated by Judith Stewart, BPharm on March 26, 2024.

FDA Approved: Yes (First approved November 14, 2022)
Brand name: Elahere
Generic name: mirvetuximab soravtansine-gynx
Previous name: mirvetuximab soravtansine
Dosage form: Injection
Company: ImmunoGen, Inc.
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Elahere (mirvetuximab soravtansine-gynx) is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate indicated 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.

Development timeline for Elahere

Mar 22, 2024Approval U.S. Food and Drug Administration (FDA) Grants Full Approval for Elahere (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients
Nov 14, 2022Approval FDA Approves Elahere (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian Cancer
May 23, 2022ImmunoGen Announces Acceptance of Biologics License Application for Mirvetuximab Soravtansine in Ovarian Cancer by US Food and Drug Administration with Priority Review

Further information

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