Piqray
Authorised
This medicine is authorised for use in the European Union
alpelisib
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Piqray 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).
Piqray can only be used when the cancer cells have receptors for certain hormones on their surface (HR-positive) and do not have large quantities of another receptor called HER2 (HER2-negative). The cancer cells must also have been shown to have a specific mutation (change) in the gene called PIK3CA identified by a validated test. Piqray is used with the medicine fulvestrant (hormone treatment for breast cancer) in patients whose cancer had worsened or did not respond to hormone treatment.
Piqray contains the active substance alpelisib
Piqray can only be obtained with a prescription and should be started by a doctor experienced in using cancer medicines.
Piqray is available as tablets to take by mouth immediately after food. The recommended dose is 300 mg once a day at about the same time each day, and treatment should continue for as long as the patient benefits from it. If the patient has unacceptable side effects, the doctor may stop treatment or reduce the dose.
For more information about using Piqray, see the package leaflet or contact your doctor or pharmacist.
In patients whose cancer cells have a PIK3CA mutation, an abnormal form of the enzyme PI3K is produced that stimulates cancer cells to divide and grow in an uncontrolled fashion. The active substance in Piqray, alpelisib, works by blocking the activity of the abnormal PI3K, thereby reducing the growth and spread of the cancer.
A main study involved 340 patients with advanced breast cancer with a PIK3CA mutation in whom hormone treatment had not worked or the cancer had come back. Patients treated with Piqray in
combination with fulvestrant lived for a median of 11 months without their disease getting worse compared with around 6 months for patients who received placebo (a dummy treatment) with fulvestrant.
Another study involved 188 patients with advanced breast cancer with a PIK3CA mutation whose cancer had worsened after hormone therapy and a medicine called a CDK4/6 inhibitor. Patients treated with Piqray in combination with fulvestrant lived for a median of around 7.4 months without their disease getting worse, compared with around 2.8 months for patients who received placebo with fulvestrant. Patients treated with Piqray and fulvestrant also lived longer overall, with a median overall survival of 29.5 months compared with 23.8 months for those receiving fulvestrant and placebo.
Studies carried out with Piqray are described in more detail in the medicine’s assessment reports.
or the full list of side effects and restrictions of Piqray, see the package leaflet.
The most common side effects with Piqray (which may affect more than 1 in 5 people) include hyperglycaemia (high blood glucose levels) which may require treatment (less frequently, reduced blood sugar), increased levels of creatinine (which may indicate kidney problems), stomatitis (inflammation of the lining of the mouth), nausea (feeling sick), vomiting, diarrhoea, decreased appetite and weight loss, abnormal blood tests for liver function, increased blood levels of lipase (which may indicate inflammation of the pancreas), rash, reduced levels of lymphocytes (a type of white blood cell), anaemia (reduced red blood cells), tiredness, hypocalcaemia (low blood levels of calcium), prolonged blood clotting time, and mucosal inflammation (inflammation of the moist body surfaces, such as the lining of the mouth).
Piqray used with fulvestrant increased the time before the disease got worse in patients with HR-positive and HER2-negative breast cancer that is advanced or has spread. In terms of the medicine’s side effects, the main concern is high blood glucose levels which may lead to diabetes and gut problems but the European Medicines Agency has recommended measures to manage this.
The Agency therefore decided that Piqray’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 Piqray have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Piqray are continuously monitored. Side effects reported with Piqray are carefully evaluated and any necessary action taken to protect patients.
Piqray received a marketing authorisation valid throughout the EU on 27 July 2020.
Product information
Latest procedure affecting product information:VR/0000317159
21/08/2026
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
- Piqray
- Active substance
- alpelisib
- International non-proprietary name (INN) or common name
- alpelisib
- Therapeutic area (MeSH)
- Breast Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01XE
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following an endocrine-based regimen (see section 5.1 and for biomarker-based patient selection see section 4.2).
News on Piqray
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