Elahere (mirvetuximab soravtansine)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- mirvetuximab soravtansine
- Company
- AbbVie Deutschland GmbH & Co. KG
- Status
- Authorised
- Therapeutic area
- Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms
- CHMP opinion
- Thu 19 Sep 2024
- EU approval
- Thu 14 Nov 2024
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005036
- ATC
- L01FX26
- Official record
- www.ema.europa.eu
Indication
Elahere as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.