Regulatory approval

Published by the Food and Drug Administration. Approved

PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

This is written in the approval document.

Citation

Novartis Pharmaceuticals Corporation. Piqray (alpelisib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212526s009lbl.pdf. Revised January 2024. Accessed October 30, 2024.

View API

Therapeutic response

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

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