Piqray (alpelisib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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