Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

Citation

Novartis Europharm Limited. Piqray (alpelisib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/piqray-epar-product-information_en.pdf. Revised October 2023. Accessed March 22, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	ER positive, HER2-negative, PIK3CA oncogenic variants	Invasive Breast Carcinoma	Alpelisib, Fulvestrant
EMA (1)	HER2-negative, PIK3CA oncogenic variants, PR positive	Invasive Breast Carcinoma	Alpelisib, Fulvestrant
EMA (1)	ER positive, HER2-negative, PIK3CA oncogenic variants, PR positive	Invasive Breast Carcinoma	Alpelisib, Fulvestrant

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2020-07-27	European Medicines Agency	Indication received approval from the European Commission.