The FDA approved Novartis’ Piqray (alpelisib) tablets in combination with the endocrine therapy fulvestrant for treatment of postmenopausal women as well as men with PIK3CA-mutated  advanced or metastatic breast cancer.

Piqray is the first novel drug approved in the FDA’s Real-Time Oncology Review pilot program, which allows the agency to begin analyzing efficacy and safety datasets prior to the submission of an application.

The approval was based on positive results from a trial of 572 postmenopausal women and men with HR-positive, HER2-negative, advanced or metastatic breast cancer whose cancer had progressed while on or after receiving an aromatase inhibitor. The treatment significantly extended progression- free survival in patients whose tumors had a PIK3CA mutation.