# Elacestrant

Elacestrant (Orserdu, Stemline Therapeutics B.V.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: ESR1 (1).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| ESR1 mutation, ER-positive, HER2-negative | Monotherapy | 2nd line, advanced | After at least one line of endocrine therapy including a CDK 4/6 inhibitor; Postmenopausal women, and men |

## Products

### Orserdu

- Company: Stemline Therapeutics B.V.
- Target: Selective estrogen receptor degrader
- Class: Anti-estrogens
- ATC: L02BA
- EU approval: 15 Sep 2023
- Label revised: 4 Aug 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/orserdu-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/orserdu-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/orserdu

Mechanism (SmPC section 5.1): Elacestrant is an oral, selective antagonist and degrader of estrogen receptor-α (ERα).

## Label wording

- **Elacestrant** (Orserdu), Breast cancer, 2nd line, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/orserdu-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/elacestrant