FDA Approves FoundationOne Liquid CDx Assay for Identifying EGFR+ NSCLC Eligible for TKI Inhibitors

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The FDA has approved the FoundationOne Liquid CDx as a companion diagnostic for identifying patients with non-small cell lung cancer harboring EGFR mutations who may benefit from treatment with specific tyrosine kinase inhibitors.

The FDA approved companion diagnostic FoundationOne Liquid CDx for the identification of non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R substitutions who could benefit from certain FDA-approved tyrosine kinase inhibitors (TKIs), according to a press release from Foundation Medicine.1

The approved tyrosine kinase inhibitors that the FoundationOne Liquid CDx can identify whether patients with EGFR-positive NSCLC will best benefit from erlotinib (Tarceva), osimertinib (Tagrisso), and gefitinib (Iressa). Moreover, FoundationOne Liquid CDx will also become a companion diagnostic to all tyrosine kinase inhibitors that are approved by the FDA for the aforementioned patient population.

“For patients [with NSCLC] whose tumors have EGFR exon 19 deletions or exon 21 substitutions, this approval opens new access avenues for targeted treatment options,” Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, said in the press release.

The FoundationOne Liquid CDx is a qualitative diagnostic tool designed to offer oncologists options when selecting the right therapy for targeting EGFR mutations in NSCLC.

The companion diagnostic tool uses targeted high throughput hybridization-based capture technology to analyze 324 genes via circulating cell-free DNA derived from patients’ anti-coagulated peripheral whole blood. The diagnostic is designated for prescription use only and reports of additional genomic findings may not be prescriptive or conclusive for labeled use of any specific product.

According to the press release, use of the FoundationOne Liquid CDx will not guarantee treatment matches for patients. Additionally, negative results do not necessarily rule out the presence of a genomic alteration. If the test indicates a negative report for companion diagnostic mutations, it is recommended that patients receive an FDA-approved tumor tissue test to confirm mutation status when possible.

Previously, the FoundationOne CDx was approved by the FDA as a companion diagnostic for identifying EGFR mutations in NSCLC in March 2022.2

References

  1. Foundation Medicine receives FDA approval for FoundationOne®Liquid CDx as a companion diagnostic for a certain group of yyrosine kinase inhibitors for treatment of non-small cell lung cancer patients. News release. Foundation Medicine. December 21, 2022. Accessed December 21, 2022. bit.ly/3jpU6uE
  2. U.S FDA approves FoundationOne®CDx as a companion diagnostic for EGFR therapeutics targeting exon 19 deletions of exon 21 substitutions in non–small cell lung cancer. News Release. March 17, 2022. Accessed December 21, 2022. https://bit.ly/3wfLUS6
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