Orserdu
What Orserdu is used for
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.
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Orserdu
- Active substance
- elacestrant
- Disease area
- Breast Neoplasms
- Medicine group
- Endocrine therapy
- ATC code
- L02BA
- Marketing authorisation holder
- Stemline Therapeutics B.V.
- Authorised in the EU since
- 2023
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Orserdu used for?
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.
What is the active substance in Orserdu?
Orserdu contains elacestrant.
Who makes Orserdu?
The EU marketing authorisation holder is Stemline Therapeutics B.V..
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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