Orserdu
Authorised
This medicine is authorised for use in the European Union
elacestrant
MedicineHumanAuthorised
Overview
Orserdu is a cancer medicine used to treat postmenopausal women and men with breast cancer that is locally advanced or metastatic (has spread to other parts of the body).
Orserdu 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. Orserdu is used in patients whose cancer has not responded to or has progressed further following at least one hormone treatment, including a medicine belonging to the class of CDK 4/6 inhibitors.
Orserdu contains the active substance elacestrant.
Orserdu can only be obtained with a prescription and treatment should be started by a doctor experienced in the use of cancer medicines.
Orserdu 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 side effects become unmanageable.
For more information about using Orserdu, see the package leaflet or contact your doctor or pharmacist.
ER-positive breast cancer is stimulated to grow when the hormone oestrogen attaches to receptors on cancer cells. The active substance in Orserdu, elacestrant, blocks and destroys these receptors; as a result, oestrogen no longer stimulates these cancer cells to grow and this slows down the growth of the cancer.
Orserdu was investigated in one main study involving 478 patients with ER-positive, HER2-negative breast cancer that had started to spread, and whose cancer had come back or did not respond to at least one previous treatment. The study showed that, among patients whose cancer cells had an ESR1 mutation, those treated with Orserdu lived on average for 3.8 months without their disease getting worse, compared with 1.9 months for patients who received standard therapy.
For the full list of side effects and restrictions with Orserdu, see the package leaflet.
The most common side effects with Orserdu (which may affect more than 1 in 10 people) include nausea (feeling sick), decreased appetite, increased levels of fats and cholesterol in the blood, vomiting, tiredness, dyspepsia (indigestion), diarrhoea, back pain, joint pain, constipation, headache, hot flush, abdominal (belly) pain, anaemia (low levels of red blood cells), increased blood levels of alanine and aspartate aminotransferase (a sign of liver problems) or creatinine (a sign of kidney problems), and decreased blood levels of calcium, sodium and potassium.
Orserdu was shown to be effective at increasing the time before the disease got worse in patients with ER-positive and HER2-negative breast cancer that is advanced or has spread and who have an ESR1 mutation. Orserdu’s safety is in line with other medicines of the same class and its side effects are considered manageable. The European Medicines Agency therefore decided that Orserdu’s benefits are greater than its risks and 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 Orserdu have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Orserdu are continuously monitored. Suspected side effects reported with Orserdu are carefully evaluated and any necessary action taken to protect patients.
Orserdu received a marketing authorisation valid throughout the EU on 15 September 2023.
Product information
Latest procedure affecting product information: N/0002
13/02/2024
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
- Orserdu
- Active substance
- elacestrant
- International non-proprietary name (INN) or common name
- elacestrant
- Therapeutic area (MeSH)
- Breast Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L02BA
Pharmacotherapeutic group
Endocrine therapyTherapeutic indication
Orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER) positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.
News on Orserdu
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