Pikray – pro
The US Food and Drug Administration (FDA) has approved the first treatment of its kind for a certain type of breast cancer caused by an inherited genetic mutation. Piqray (alpelisib) is a targeted therapy called a PI3K inhibitor. It’s specifically for advanced breast cancer patients – postmenopausal women and men – whose tumors have the PIK3CA mutation and are hormone receptor (HR) positive and HER2 negative. PIK3CA mutations are found in about 30-40% of breast cancers. The drug is meant to be used along with Faslodex (fulvestrant), a hormone therapy already approved by the FDA.
André, F., et al. (2019). Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med 2019; 380:1929.
Kodahl AR, Ehmsen S, Pallisgaard N, et al. Correlation between circulating cell-free PIK3CA tumor DNA levels and treatment response in patients with PIK3CA-mutated metastatic breast cancer. Mol Oncol. 2018;12(6):925–935. doi:10.1002/1878-0261.12305
FDA Oncology Update. (2019). American health & drug benefits, 12(4), 198200.
Rodon, J., et al. (2018). A Phase Ib, open-label, dose-finding study of alpelisib in combination with paclitaxel in patients with advanced solid tumors. Oncotarget, 9(60), 3170931718. doi:10.18632/oncotarget.25854