Etcamah
Authorised
This medicine is authorised for use in the European Union
camizestrant
MedicineHumanAuthorised
Latvian is available via eTranslation, the European Commission's machine translation service.
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Etcamah is a cancer medicine used to treat adults with breast cancer that is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body); it is used in combination with a medicine belonging to the class of CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib).
Etcamah is 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. Etcamah is used in patients whose cancer has not progressed during hormone treatment plus a CDK4/6 inhibitor.
When the medicine is used in women who have not yet reached the menopause (pre-menopausal or perimenopausal) and in men, it should be given with a luteinising hormone-releasing hormone (LHRH) agonist or antagonist (a medicine that lowers blood levels of the hormones oestrogen and progesterone).
Etcamah contains the active substance camizestrant.
Etcamah can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Etcamah is available as tablets to be taken by mouth once a day. Treatment should continue for as long as the patient benefits from it, or until they develop unacceptable side effects.
For more information about using Etcamah, 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 (targets) in cancer cells. The active substance in Etcamah, camizestrant, blocks and destroys these receptors; as a result, oestrogen no longer stimulates the cancer cells to grow which slows down the growth of the cancer.
Etcamah was investigated in one main study involving 315 patients with ER-positive, HER2-negative breast cancer with an ESR1 mutation that had started to spread, and who had been treated with the hormone cancer medicines letrozole or anastrozole in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for at least six months without their cancer progressing. Half of the patients (158) continued with this therapy, and half (157) were switched to Etcamah plus a CDK4/6 inhibitor.
In the study, the median progression free survival (PFS) was around 17 months with Etcamah and around 9 months with letrozole / anastrozole, both in combination with a CDK4/6 inhibitor. PFS is how long patients lived without their disease getting worse.
The median survival (how long patients lived) was 41 months with Etcamah and 40 months with letrozole / anastrozole.
Studies carried out with Etcamah are described in more detail in the medicine’s assessment report.
For the full list of side effects and restrictions with Etcamah, see the package leaflet.
The most common side effects with Etcamah in combination with a CDK4/6 inhibitor (which may affect more than 1 in 10 people) include neutropenia (low level of neutrophils, a type of white blood cell), visual effects (including photopsia, the perception of flashes of light in the field of vision), infections, diarrhoea, nausea (feeling sick), anaemia (low levels of red blood cells), tiredness, bradycardia (slow heart rate) and leucopenia (low levels of white blood cells). Among these, side effects specifically associated with Etcamah were visual effects and bradycardia.
Some side effects can be serious. The most frequent (which may affect up to 1 in 10 people) include infections and fever.
Etcamah must not be used during breastfeeding.
Etcamah, in combination with a CDK4/6 inhibitor, 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.
Overall, the safety profile of Etcamah was considered similar to that of hormone-based cancer treatments; the majority of serious side effects seen in the main study were known side effects of CDK4/6 inhibitors, while bradycardia and visual disturbances appear to be specific for Etcamah. Side effects affecting the heart are considered manageable with warnings and monitoring recommendations in the product information.
The European Medicines Agency therefore decided that Etcamah’s benefits are greater than its risks and that it can be authorised for use in the EU.
To further characterise the long-term efficacy of the medicine, the company that markets Etcamah will submit the final results of the main study.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Etcamah have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Etcamah are continuously monitored. Suspected side effects reported with Etcamah are carefully evaluated and any necessary action is taken to protect patients.
Etcamah received a marketing authorisation valid throughout the EU on 20 July 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
- Etcamah
- Active substance
- camizestrant
- International non-proprietary name (INN) or common name
- camizestrant
- Therapeutic area (MeSH)
- Breast Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L02BA05
Pharmacotherapeutic group
Endocrine therapyTherapeutic indication
Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1‑mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor (for biomarker based patient-selection, see section 4.2 and 5.1).
Assessment history
News on Etcamah
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