Imlunestrant
Imlunestrant (Inluriyo, Eli Lilly Nederland B.V.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: ESR1 (1).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Breast cancer1 | |||
ESR1 mutation, ER-positive, HER2-negative | Monotherapy | 2L 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 |
Full text of section 4.1 (therapeutic indications)
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). In pre- or perimenopausal women, or men, Inluriyo should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Label history
1 change to the Inluriyo label since 2026, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes