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David S. Ettinger, MD, FACP, FCCP


FDA Brief: Companion Diagnostic Approved for Tyrosine Kinase Inhibitor Treatment of NSCLC

By: JNCCN 360 Staff
Posted: Thursday, December 22, 2022

On December 21, Foundation Medicine announced that the U.S. Food and Drug Administration (FDA) has approved its FoundationOne®Liquid CDx as a companion diagnostic to identify patients with non–small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with a group of current and future EGFR tyrosine kinase inhibitors approved by the FDA for this indication. For prescription use only, this next-generation sequencing–based, in vitro diagnostic test employs targeted high throughput hybridization–based capture technology to analyze 324 genes using circulating cell-free DNA isolated from plasma derived from anticoagulated peripheral whole blood of patients with advanced cancer.

The current therapies for which FoundationOne Liquid CDx is a companion diagnostic under the group approvals are erlotinib, osimertinib, and gefitinib. Moving forward, FoundationOne Liquid CDx will automatically become a companion diagnostic for future tyrosine kinase inhibitors within this group for the treatment of NSCLC that are approved by the FDA.

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