FDA Approves FoundationOne CDx as Companion Diagnostic Test for Piqray Treatment

FDA Approves FoundationOne CDx as Companion Diagnostic Test for Piqray Treatment
The U.S. Food and Drug Administration (FDA) has approved Foundation Medicine’s FoundationOne CDx as a companion diagnostic test for identifying advanced breast cancer patients with a PIK3CA mutation suitable for treatment with Piqray (alpelisib). Piqray was approved in May, in combination with Faslodex (fulvestrant), for postmenopausal women and men with HR-positive, HER2-negative advanced breast cancer who had failed prior hormone therapy and carried a mutation in the PIK3CA gene. It is the first and only treatment approved for the PIK3CA-mutated breast cancer population. By examining multiple genes and select gene rearrangements, FoundationOne CDx is intended to select breast cancer patients who may benefit from Piqray. Due to its broad genetic analysis, it also is approved as a companion diagnostic test for 18 additional targeted therapies. These include treatments for multiple solid tumors, including HER2-targeted therapies for breast cancer and PARP inhibitors for ovarian cancer. “Foundation Medicine is proud to achieve another FDA approval for FoundationOne CDx as a companion diagnostic f
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