On August 7, the U.S. Food and Drug Administration (FDA) approved FoundationOne® Liquid CDx and Guardant360® CDx as next generation sequencing based liquid biopsy companion diagnostics for osimertinib (Tagrisso®) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test; and for patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
See full prescribing information.
About FoundationOne® Liquid CDx.
About Guardant360® CDx.
Posted 9/24/2020