Inluriyo (imlunestrant)
- Region
- 🇪🇺 EU
- Active substance
- imlunestrant
- Company
- Eli Lilly Nederland B.V.
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms
- CHMP opinion
- Thu 13 Nov 2025
- EU approval
- Fri 09 Jan 2026
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006184
- ATC
- L02BA
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
Inluriyo (imlunestrant) approved in the EU
Marketing authorisation to Eli Lilly Nederland B.V.; Additional monitoring · source
Inluriyo (imlunestrant): CHMP positive opinion
Eli Lilly Nederland B.V.; Additional monitoring · source
Same substance in other markets
- 🇺🇸 Inluriyo Approved · Eli Lilly And Co
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.