# Imlunestrant

Imlunestrant (Inluriyo, Eli Lilly Nederland 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 prior treatment with an endocrine based regimen; In pre- or perimenopausal women, or men, Inluriyo should be combined with a luteinising hormone-releasing hormone (LHRH) agonist |

## Products

### Inluriyo

- Company: Eli Lilly Nederland B.V.
- Target: Selective estrogen receptor degrader
- Class: Anti-estrogens
- ATC: L02BA
- EU approval: 9 Jan 2026
- Label revised: 23 Feb 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/inluriyo-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/inluriyo-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/inluriyo

Mechanism (SmPC section 5.1): Imlunestrant antagonises and degrades wild-type and mutant ERα, inhibiting oestrogen receptor-dependent gene transcription and cell proliferation in ER-positive breast cancer cells.

## Label wording

- **Imlunestrant** (Inluriyo), Breast cancer, 2nd line, advanced: “Inluriyo is indicated as monotherapy for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen (for biomarker-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/inluriyo-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/imlunestrant