On October 27, the U.S. Food and Drug Administration (FDA) approved the FoundationOne Liquid CDx test for three new companion diagnostic indications to help match patients who may benefit from treatment with specific FDA-approved targeted therapies. The new indications are for alpelisib (Piqray) in advanced or metastatic breast cancer; rucaparib (Rubraca) in advanced ovarian cancer; and alectinib (Alecensa) in ALK-positive metastatic non–small cell lung cancer (NSCLC). The FDA also approved a label expansion for FoundationOne Liquid CDx to report additional select copy number alterations and genomic rearrangements.
FoundationOne Liquid CDx analyzes the largest genomic region of any FDA-approved comprehensive liquid biopsy test and was approved in August 2020 to provide tumor mutation profiling in accordance with professional guidelines for patients with any solid tumor. Concurrently, it was approved as a companion diagnostic for a poly (ADP-ribose) polymerase (PARP) inhibitor approved by the FDA for the treatment of patients with metastatic castration-resistant prostate cancer with qualifying BRCA1 or BRCA2 alterations, and for three first-line EGFR tyrosine kinase inhibitors for the treatment of non–small cell lung cancer.
The October 27 approval expands FoundationOne Liquid CDx’s companion diagnostic indications to include the following targeted therapies: