EMA
approval
· 2026-03-25
EMA Authorised: Orserdu (elacestrant) — Stemline Therapeutics B.V.
Summary
The European Medicines Agency authorised Orserdu (elacestrant) for ER-positive, HER2-negative advanced or metastatic breast cancer; decision date 25 March 2026.
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Breast Neoplasms. MAH: Stemline Therapeutics B.V.. Decision date: 25/03/2026