Piqray

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alpelisib

Authorised
This medicine is authorised for use in the European Union.

Overview

Piqray is a cancer medicine used to treat postmenopausal women and men with breast cancer that is locally advanced or 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’. Piqray is used with the medicine fulvestrant (hormone treatment for breast cancer) after hormone treatment used alone has failed.

Piqray contains the active substance alpelisib.

This EPAR was last updated on 05/12/2022

Authorisation details

Product details
Name
Piqray
Agency product number
EMEA/H/C/004804
Active substance
Alpelisib
International non-proprietary name (INN) or common name
alpelisib
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XE
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Novartis Europharm Limited 
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
27/07/2020
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
D04 A9N6 
Ireland

Product information

20/10/2022 Piqray - EMEA/H/C/004804 - II/0013

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic 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 endocrine therapy as monotherapy (see section 5.1).

Assessment history

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