FDA Approves Companion Diagnostic for Certain Group of TKIs in the Treatment of NSCLC


The FDA's approval includes the group indication for all current and future EGFR TKIs, including erlotinib, osimertinib, and gefitinib.

A companion diagnostic (FoundationOne Liquid CDx; Foundation Medicine) that can be used to identify patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitutions and are candidates for treatment with a group of current and future EGFR tyrosine kinase inhibitors (TKI) has been approved by the FDA for this indication, according to a press release. Further, the approval is for the group of current and future EGFR TKIs, which is possible because the FDA was able to determine that sufficient evidence was available to demonstrate that the companion diagnostic is appropriate for use for this group of therapies.

“For patients [NSCLC] whose tumors have EGFR exon 19 deletions or exon 21 substitutions, this approval opens new access avenues for targeted treatment options,” said Mia Levy, MD, PhD, chief medical officer of Foundation Medicine, in the press release. “Following 3 recent group companion diagnostic approvals for Foundation Medicine’s tissue-based test, FoundationOne CDx, this first group approval for FoundationOne Liquid CDx builds upon the momentum for more efficient and innovative regulatory approaches to the companion diagnostic approval process. These efforts help to maintain the high-quality standards and rigor of the process, while streamlining the approach to developing TKIs to get these treatments to patients faster.”

The companion diagnostic works whereby segments of the DNA molecule called exons, which contain information regarding the process for coding proteins, are assessed for specific mutations. The EGFR mutations observed in patients with NSCLC are present because of mutations in 2 specific exons—deletions in exon 19 and substitutions in exon 21. These 2 mutations are the second most common drivers of tumor growth in patients with NSCLC. Because of their role in tumor growth, pinpointing these 2 mutations provides oncologists with greater insight when developing a targeted treatment plan for patients.

Further, as a companion diagnostic that can be used with all therapies in this group that targets these mutations in patients with NSCLC, this newly approved diagnostic offers oncologists with flexibility in the therapy selection process, as they are able to consider all FDA approved treatment options within this group of therapies.

Currently, the therapies available for assessment by this companion diagnostic are erlotinib (Tarceva; Genentech), osimertinib (Tagrisso; AstraZeneca Pharmaceuticals), and gefitinib (Iressa; AstraZeneca Pharmaceuticals). In the future, other FDA-approved TKIs in this group will automatically be included for use with this companion diagnostic as well.


Foundation Medicine Receives FDA Approval for FoundationOne®Liquid CDx as a Companion Diagnostic for a Certain Group of Tyrosine Kinase Inhibitors for Treatment of Non-Small Cell Lung Cancer Patients. Cambridge, MA: Foundation Medicine; December 21, 2022. https://www.businesswire.com/news/home/20221221005064/en

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