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FDA Approves Treatment For Metastatic Breast Cancer Treatment

Posted at 10:09 AM, Jul 02, 2019
and last updated 2019-07-02 10:09:36-04

Americans are more aware than ever about genetic testing and mutations in metastatic breast cancer, such as the increased risks associated with the BRCA1/2 gene. What they may not know is that tumors can develop mutations thatimpact how the breast cancer responds to treatment. Following a recent FDA approval of a new medicine, postmenopausal women and men living with HR+/HER2- metastatic breast cancer who have progressed on or after an endocrine-based regimen may be eligible for treatment if a PIK3CA mutation is detected.

The FDA recently approved PIQRAY® (alpelisib)*, a prescription medicine used in combination with the medicine fulvestrant specifically to treat women who have gone through menopause and men who have HR+/HER2- advanced breastcancer or breast cancer that has spread to other parts of the body (metastatic), with an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and whose disease has progressed on or after endocrine therapy1. Thisimportant milestone marks the first time physicians are able to test advanced or metastatic breast cancer patients for a PIK3CA mutation and develop a personalized treatment plan based on the patient’s PIK3CA mutation status.

Mutations in a gene called PIK3CA occur in approximately 40% of HR+/HER2- breast cancers, the most common type of breast cancer2. PIK3CA mutations may lead to tumor growth, cause resistance to endocrine therapies and result in apoor overall prognosis3,4. Dr. Virginia Kaklamani, Professor of Hematology/Oncology at UT Health San Antonio , is available to discuss this new treatment option for patients with HR+/HER2- metastatic breast cancer and the significance ofaddressing PIK3CA mutations.

Shirley Mertz, President of the Metastatic Breast Cancer Network (MBCN), is also available to share her perspective on the importance for patients of knowing their breast cancer type.

*Your health care provider will test your cancer for an abnormal “PIK3CA” gene to make sure that PIQRAY is right for you. It is not known if PIQRAY is safe and effective in children.