New FDA Approval: A PI3K Inhibitor - Metastatic Breast Cancer Trial Talk

FDA Approval

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

More About PI3K and Cancer (for those who want to learn more about the science)

Current Breast Cancer Clinical Trials Targeting PI3K

Last Modified on March 4, 2021



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