FDA Approves Companion Diagnostic for Alpelisib in PIK3CA-Mutated Metastatic Breast Cancer
Posted: Monday, December 9, 2019
On December 4, FoundationOne CDx received approval from the U.S. Food and Drug Administration (FDA) to be used as a companion diagnostic for alpelisib (Piqray) in combination with fulvestrant in the treatment of postmenopausal women and men with hormone receptor–positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer after disease progression on or after an endocrine-based regimen. In May 2019, alpelisib in combination with fulvestrant was approved specifically for patients with hormone receptor–positive, HER2-negative advanced breast cancer who have a PIK3CA mutation.
FoundationOne CDx is a next-generation sequencing–based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability and tumor mutational burden using DNA isolated from formalin-fixed paraffin-embedded tumor tissue specimens. FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling.
