Piqray - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

alpelisib

Opinion

On 23 July 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Piqray. The marketing authorisation holder for this medicinal product is Novartis Europharm Limited.

The CHMP adopted an extension to the existing indication as follows:

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 therapy as monotherapy (see section 5.1 and for biomarker based patient-selection see section 4.2).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold, removed text as strikethrough.

CHMP post-authorisation summary of positive opinion for Piqray (VR0000317159)

Adopted

Key facts

• Name of medicine:
  Piqray
• EMA product number:
  EMEA/H/C/004804
• Active substance:
  alpelisib
• International non-proprietary name (INN) or common name:
  alpelisib
• Therapeutic area (MeSH):
  Breast Neoplasms
• Anatomical therapeutical chemical (ATC) code:
  L01XE
• Marketing authorisation holder:
  Novartis Europharm Limited
• Date of opinion:
  23/07/2026
• Status:
  Positive