FDA approves FoundationOne Liquid CDx as companion diagnostic for several cancer therapies
Click Here to Manage Email Alerts
The FDA approved the FoundationOne Liquid CDx test as a companion diagnostic device to help identify multiple additional biomarkers in cell-free DNA isolated from plasma, according to a press release from the agency.
The approval applies to the use of the next-generation sequencing-based assay to detect BRCA1, BRCA2 and ATM mutations in men with metastatic castration-resistant prostate cancer eligible for treatment with olaparib (Lynparza, AstraZeneca); BRCA1 and BRCA2 mutations in women with ovarian cancer eligible for rucaparib (Rubraca, Clovis Oncology); ALK rearrangements in patients with non-small cell lung cancer eligible for alectinib (Alecensa, Genentech); and PIK3CA mutations in patients with breast cancer eligible for alpelisib (Piqray, Novartis).
The FDA based its approval of the FoundationOne Liquid CDx test (Foundation Medicine) for these indications on retrospective testing of available plasma samples from patients in clinical trials that supported the approvals of rucaparib, alpelisib, alectinib or olaparib. Results showed maintained efficacy of these treatments among patients with the mutations and alterations associated with the FoundationOne CDx approvals.
If these mutations and alterations are not detected in the blood, clinicians should perform a tumor biopsy to confirm that they are not present, according to the FDA.
In October, the FDA approved the FoundationOne CDx test to detect NTRK1, NTRK2 and NTRK3 gene fusions in tumor tissue DNA of patients with solid tumors eligible for treatment with larotrectinib (Vitrakvi, Bayer).
Read more about
Click Here to Manage Email Alerts