Inluriyo
Authorised
This medicine is authorised for use in the European Union
imlunestrant
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Inluriyo is an anti-hormonal cancer medicine used on its own in adults to treat breast cancer that is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body).
It can only be used when the cancer cells have receptors (targets) for the hormone oestrogen on their surface (oestrogen receptor-positive; ER-positive) and do not have large quantities of a receptor for human epidermal growth factor called HER2 (HER2-negative). The cancer cells must also have been shown to have a specific mutation (change) in the gene called ESR1.
Inluriyo is used in adults whose cancer has progressed further following previous treatment with hormone-based medicines. When the medicine is used in women who have not yet reached the menopause (pre-menopausal or perimenopausal) and men, it should be given with a luteinising hormone-releasing hormone (LHRH) agonist (a medicine that lowers blood levels of the hormones oestrogen and progesterone).
Inluriyo contains the active substance imlunestrant.
Inluriyo can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Inluriyo is available as tablets to be taken by mouth once a day. Treatment should continue as long as the patient benefits from it or until they develop unacceptable side effects.
For more information about using Inluriyo, see the package leaflet or contact your doctor or pharmacist.
ER-positive breast cancer is stimulated to grow when the hormone oestrogen attaches to ER receptors on cancer cells. The active substance in Inluriyo, imlunestrant, blocks and destroys these receptors; as a result, oestrogen no longer stimulates these cancer cells to grow which slows down the growth of the cancer.
A main study showed that Inluriyo increased the time adults with ER-positive, HER2-negative breast cancer with an ESR1 mutation lived without their cancer getting worse compared with standard of care (hormone-based treatment that medical experts consider most appropriate).
The study involved 874 adults with ER-positive, HER2-negative breast cancer that was locally advanced or had started to spread, and whose cancer had come back or did not respond following previous treatment with a hormone-based medicine. The study involved participants with and without an ESR1 mutation.
Participants were given either Inluriyo on its own, standard of care or Inluriyo given with abemaciclib, another cancer medicine. Those given Inluriyo (331 people) and standard of care (330 people) both lived on average for around 5.5 months without their cancer getting worse. However, those with an ESR1 mutation given Inluriyo on its own (138 people) lived on average for around 5.5 months without their cancer getting worse compared with around 3.8 months for those with an ESR1 mutation given standard of care (118 people).
For the full list of side effects and restrictions with Inluriyo, see the package leaflet.
The most common side effects with Inluriyo (which may affect more than 1 in 10 people) include increased liver enzymes (proteins) which can be a sign of liver problems, tiredness, diarrhoea, nausea (feeling sick) and vomiting.
Inluriyo must not be used in women who are breast-feeding.
Inluriyo was shown to be effective at increasing the time before the disease got worse in adults with ER-positive, HER2-negative breast cancer with an ESR1 mutation that was locally advanced or had started to spread, and whose cancer did not respond following treatment with a hormone-based medicine. However, there were some limitations with the main study including a limited number of patients with an ESR1 mutation included in the study. Furthermore, there was only a small difference between the benefits observed with Inluriyo and those achieved with standard of care.
Overall, the safety profile of Inluriyo was considered similar to that of hormone-based cancer treatments; the main difference is that more side effects affecting the stomach and gut were observed with Inluriyo compared with hormone-based treatments.
The European Medicines Agency therefore decided that Inluriyo’s benefits are greater than its risks and that it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Inluriyo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Inluriyo are continuously monitored. Suspected side effects reported with Inluriyo are carefully evaluated and any necessary action taken to protect patients.
Inluriyo received a marketing authorisation valid throughout the EU on 9 January 2026.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Inluriyo
- Active substance
- imlunestrant tosilate
- International non-proprietary name (INN) or common name
- imlunestrant
- Therapeutic area (MeSH)
- Breast Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L02BA
Pharmacotherapeutic group
Endocrine therapyTherapeutic 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.
News on Inluriyo
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