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FDA approved

FDA Granted Approval Of First Companion Diagnostic Test for Expanded EGFR TKIs in NSCLC

  • April 16, 2021
  • 2 mins read

According to a press release, Roche (the test developer) announced that, “The Food and Drug Administration has approved the cobas EGFR Mutation Test v2 in form of a companion diagnostic for EGFR TKIs as treatment of patients with EGFR-mutant NSCLC, which is the first assay got the approval for this indication. 

The use of this assay will be as a companion diagnostic for the all five FDA approved epidermal growth factor receptor TKIs that specifically target EGFR L858R mutations as well as EGFR exon-19 deletions, marking this as the first liquid biopsy test established for the expanded EGFR TKI therapies in NSCLC.

This indication also enables for the assay in order to be used for any future epidermal growth factor receptor TKIs that may become approved by the FDA that target the same mutations without requiring individual clinical trials with the test for each new treatment.

According to Neil Gunn, head of Roche, “The clinicians can now have higher confidence in the robustness, reliability and proven clinical utility of the cobas epidermal growth factor receptor mutation test v2 when assessing lung cancer patients who may get advantage from the targeted epidermal growth factor receptor TKI therapies.” 

“By the approval of a single test for a broad population of therapies, this new as well as innovative approach by the FDA may pave the way for the future epidermal growth factor receptor TKI therapies in order to utilize cobas epidermal growth factor receptor mutation test v2 in order to help evaluate the patients for the personalized medicine,” Neil Gunn added. 

The test specifically is a real-time PCR test for the qualitative detection of 42 epidermal growth factor receptor mutations across exons 18 through 21 in patients with non-small cell lung cancer.

These mutations are found with DNA isolated from either formalin fixed paraffin embedded tumor tissue or circulating tumor DNA from plasma originated from the ethylenediamine tetraacetic acid anti coagulated peripheral whole blood.

In several carried out clinical trials, the assay has been validated as a companion diagnostic for the epidermal growth factor receptor TKI therapies in the first-line as well as the second line settings for the advanced non-small cell lung cancer.

One such carried out study looked at detection of epidermal growth factor receptor mutations in patients with the lung adenocarcinoma with several PCR-based assays, and repeatability of these tests in the daily practice.

Totally, 345-samples were assessed with the cobas epidermal growth factor receptor mutation test v2 and 103 with the Therascreen EGFR Plasma RGQ PCR Kit.

Cobas test was appeared to be superior to the Therascreen assay and demonstrated 100% reproducibility.

These Food and Drug Administration approved epidermal growth factor receptor TKIs include osimertinib (Tagrisso), dacomitinib (Vizimpro), gefitinib (Iressa), afatinib (Gilotrif), and erlotinib (Tarceva). Gefitinib and erlotinib specifically are the first generation epidermal growth factor receptor TKIs, while afatinib and dacomitinib are the second generation agents and osimertinib is a third generation epidermal growth factor receptor TKI.

Reference:

https://www.targetedonc.com/view/fda-approves-first-companion-diagnostic-test-for-expanded-egfr-tkis-in-nsclc