FDA Approves FoundationOne CDx as a Companion Diagnostic for Alpelisib/Fulvestrant Treatment in Breast Cancer

December 5, 2019 – On December 4, the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx to be used as a companion diagnostic for alpelisib in combination with fulvestrant for the treatment of postmenopausal female patients as well as male patients with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following disease progression on or after an endocrine-based regimen. FoundationOne CDx … (leggi tutto)