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EMA approval · 2026-03-25

EMA Authorised: Orserdu (elacestrant) — Stemline Therapeutics B.V.

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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

  • Orserdu (Elacestrant)

Snippet

Status: Authorised. Therapeutic area: Breast Neoplasms. MAH: Stemline Therapeutics B.V.. Decision date: 25/03/2026