Test indicated as a CDx for five NSCLC therapies

WASHINGTON — The FDA approved the cobas EGFR Mutation Test V2 as a companion diagnostic (CDx) for several non-small cell lung cancer (NSCLC) therapies.

With this new approval, the real-time polymerase chain reaction test can be used in conjunction with five FDA-approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies that target EGFR mutations L858R and Exon 19 Deletions, Roche, the test’s manufacturer, explained in a company press release —and, the company added, this approval makes the text the first CDx approved for this group of therapies in patients with NSCLC.

The five approved EGFR TKI therapies are afatinib (Gilotrif), gefitinib (Iressa), dacomitinib (Vizimpro), erlotinib (Tarceva), and osimertinib (Tagrisso). The approval also allows the test to be used as a CDx for any future approved EGFR TKI therapies that target the same mutations, with no additional clinical trials or approvals required, the company noted.

The cobas EGFR Mutation Test V2 detects defined EGFR mutations in NSCLC patients “using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating tumor DNA (ctDNA) from plasma derived from ethylenediamine tetraacetic acid (EDTA) anti-coagulated peripheral whole blood,” Roche explained.

John McKenna, Associate Editor, BreakingMED™

Cat ID: 24

Topic ID: 78,24,730,24,192,151,65,925