FDA Approves FoundationOne Liquid CDx as Companion Diagnostic Test for Piqray Treatment

FDA Approves FoundationOne Liquid CDx as Companion Diagnostic Test for Piqray Treatment
The U.S. Food and Drug Administration (FDA) has expanded the approval of Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic test for identifying advanced or metastatic breast cancer patients suitable for treatment with NovartisPiqray (alpelisib). The approval covers men and postmenopausal women who have experienced disease progression during or after endocrine therapy. Additional new indications include those for patients with advanced ovarian cancer who may benefit from treatment with Rubraca (rucaparib) and for treatment with Alecensa (alectinib) in patients with a certain type of metastatic non-small cell lung cancer (mNSCLC). A companion test is used to match a patient to a specific therapy. In the case of FoundationOne Liquid CDx, the test examines 324 genes from circulating tumor cells — cancer cells shed from the primary tumor or its metastases —that circulate in the blood. “FoundationOne Liquid CDx offers oncologists an important and minimally invasive tool to consider when making treatment decisions for their patients, regardless of the type of cancer they have,” Brian Alexander, MD, chief
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