EMA — authorised 9 January 2026
- Application: EMEA/H/C/006184
- Marketing authorisation holder: Eli Lilly Nederland B.V.
- Local brand name: Inluriyo
- 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.
- Status: approved
On 9 January 2026, the European Medicines Agency (EMA) granted marketing authorisation for Inluriyo, a treatment for adult patients with oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer. This authorisation is for patients with an activating ESR1-mutation who have disease progression following prior treatment with an endocrine-based regimen. Inluriyo is available as a monotherapy for postmenopausal women, and in combination with a luteinising hormone-releasing hormone (LHRH) agonist for pre- or perimenopausal women or men.