Novartis breast cancer drug marks first approval of PI3Kα inhibitor

Piqray alpelisib became the first FDA-approved PI3Kα inhibitor on Friday, as well as the first novel drug approved under the agency's Real-Time Oncology Review pilot program. FDA approved the breast cancer drug about three months ahead of its Aug. 18 PDUFA date.

Piqray from Novartis AG (NYSE:NVS; SIX:NOVN) is approved in combination with endocrine therapy fulvestrant to treat postmenopausal women, and men, with hormone receptor-positive, HER2-negative, PI3KCA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen...