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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mirvetuximab soravtansine-gynx
Trade Name: Elahere
Date Designated: 07/14/2014
Orphan Designation: Treatment of ovarian cancer
Orphan Designation Status: Designated/Approved
ImmunoGen, Inc.
830 Winter Street
Waltham, Massachusetts 02451
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: mirvetuximab soravtansine-gynx
Trade Name: Elahere
Marketing Approval Date: 11/14/2022
Approved Labeled Indication: treatment of adult patients with folate receptor-alpha (FR?) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.
Exclusivity End Date: 11/14/2029 
Exclusivity Protected Indication* :  treatment of adult patients with folate receptor-alpha (FR?) positive, platinum-resistant epithelial ovarian cancer, as detected by an FDA-approved test, who have received one to three prior systemic treatment regimens
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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