🇪🇺 Elacestrant dihydrochloride in European Union

EMA authorised Elacestrant dihydrochloride on 15 September 2023

Marketing authorisation

EMA — authorised 15 September 2023

  • Application: EMEA/H/C/005898
  • Marketing authorisation holder: Stemline Therapeutics B.V.
  • Local brand name: Orserdu
  • 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.
  • Status: approved

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Frequently asked questions

Is Elacestrant dihydrochloride approved in European Union?

Yes. EMA authorised it on 15 September 2023.

Who is the marketing authorisation holder for Elacestrant dihydrochloride in European Union?

Stemline Therapeutics B.V. holds the EU marketing authorisation.