NEW YORK (GenomeWeb) – The US Food and Drug Administration has approved Novartis' alpelisib (Piqray), the first PI3K inhibitor for advanced or metastatic breast cancer patients with PIK3CA mutations.

The drug is approved in combination with the endocrine therapy fulvestrant as a treatment for hormone receptor-positive, HER2-negative, PIK3CA-mutated breast cancer, after progressing on an endocrine based regimen.