On December 21, Foundation Medicine, Inc, announced that the U.S. Food and Drug Administration (FDA) 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. 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 that are approved by the FDA for NSCLC.
Group approvals are granted when evidence is sufficient to conclude that a companion diagnostic is appropriate for use with a specific group of therapies, rather than specific products. As a companion diagnostic for all therapies in this group targeting these mutations in NSCLC, FoundationOne Liquid CDx offers oncologists flexibility when selecting the right therapy for their patients and ensures all FDA-approved treatment options are considered within this group of therapies.
EGFR mutations seen in patients with NSCLC patients are due to mutations within two specific exons—deletions in exon 19 and substitutions in exon 21. Since EGFR mutations are the second most common drivers of tumor growth in patients with NSCLC, the ability to pinpoint two of the largest catalysts of cancer growth in these patients provides oncologists with more insight for their targeted treatment planning.
About FoundationOne Liquid CDx
FoundationOne Liquid CDx is a qualitative next-generation sequencing–based in vitro diagnostic test for prescription use only that uses targeted high-throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA isolated from plasma derived from anticoagulated peripheral whole blood of patients with advanced cancer. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling.
Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be referred for tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible.
For the complete label—including companion diagnostic indications and complete risk information—please visit www.F1LCDxLabel.com.
