Orserdu (elacestrant)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- elacestrant
- Company
- Stemline Therapeutics B.V.
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms
- CHMP opinion
- Thu 20 Jul 2023
- EU approval
- Fri 15 Sep 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005898
- ATC
- L02BA
- Official record
- www.ema.europa.eu
Indication
Orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER) positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.
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.