In May, the U.S. Food and Drug Administration (FDA) approved Piqray® (alpelisib) for treating advanced breast cancer. It is approved for use in combination with Faslodex® (fulvestrant) to treat postmenopausal women and men with HR-positive, HER2-negative, PIK3CA-mutated, advanced breast cancer who have already been treated with at least one hormone therapy. The FDA also approved a tumor test to look for the PIK3CA mutation.
Piqray® (alpelisib) is a PI3K (Phosphoinositide 3-kinase) inhibitor. The PI3K enzymes are part of the PI3K/AKT/mTOR pathway, which helps control how cells communicate as well as cell growth.
PIK3CA is the gene that is involved in making PI3K enzymes. A mutation in the PIK3CA gene leads to abnormal PI3K function, which can be targeted by Piqray®. Approximately 40% of patients living with HR+/HER2- breast cancer have this PIK3A mutation.
Use these links to learn more about the FDA approval and how PI3K inhibitors work and to find clinical trials on Metastatic Trial Search for Piqray and other therapies being tested in patients whose tumors have a PIK3CA mutation.
First PI3K Inhibitor Approved for Advanced Breast Cancer
- U.S. FDA: FDA Approves First PI3K Inhibitor for Advanced Breast Cancer
- ClinicalTrials.gov: Clinical Trial Results That Led to FDA Approval
- Biospace.com: Novartis Wins Approval For First-of-its-Kind Breast Cancer Treatment
- Piqray.com: Understanding Piqray®
- Novartis: Novartis Information on Patient Assistance/Co-Pay Program
- Living Beyond Breast Cancer (LBBC): Webinar: New Approval for MBC: Alpelisib
- Living Beyond Breast Cancer (LBBC): FDA Approves Alpelisib, First PI3K Inhibitor for Breast Cancer
More About PI3K and Cancer (for those who want to learn more about the science)
- Molecular Cancer: Targeting PI3K in Cancer: Mechanisms and Advances in Clinical Trials
Current Breast Cancer Clinical Trials Targeting PI3K
- Metastatic Trial Search: Clinical Trials Targeting PI3K
Last Modified on March 4, 2021