FDA Approves First Companion Diagnostic for Expanded EGFR TKI Therapies in NSCLC

The FDA has approved expanded claims for the Cobas EGFR Mutation Test v2 as a companion diagnostic for a broader group of therapies in the treatment of non-small cell lung cancer (NSCLC), according to Roche, the developer of the companion diagnostic.

The cobas EGFR Mutation Test v2 is a real-time polymerase chain reaction test for the qualitative detection of defined mutations of the EGFR gene in patients with NSCLC, with results typically available in less than 8 hours.

The expansion now allows the test to be used as a companion diagnostic for all 5 FDA-approved EGFR tyrosine kinase inhibitor (TKI) therapies targeting EGFR mutations L858R and Exon 19 Deletions in accordance with the approved therapeutic product labelling. Additionally, the group claim will also allow the test to be used as a companion diagnostic for any EGFR TKI therapies targeting the same mutations approved in the future, without the need to conduct individual clinical studies with the test for each new therapy.

Importantly, this is the first companion diagnostic approved for this group of therapies in patients with NSCLC.

“Clinicians can now have greater confidence in the robustness, reliability and proven clinical utility of the cobas EGFR Mutation Test v2 when evaluating lung cancer patients who may benefit from targeted EGFR TKI therapies,” Neil Gunn, head of Roche Sequencing Solutions, said in a press release. “By approving a single test for a broad group of therapies, this new and innovative approach by the FDA can pave the way for future EGFR TKI therapies to utilize the cobas EGFR Mutation Test v2 to help identify patients for personalized medicine.”

Reference:

Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer [news release]. Pleasanton, California. Published October 29, 2020. Accessed October 30, 2020. https://www.prnewswire.com/news-releases/roche-receives-fda-approval-for-the-cobas-egfr-mutation-test-v2-as-the-first-companion-diagnostic-test-for-expanded-egfr-tki-therapies-in-patients-with-non-small-cell-lung-cancer-301163170.html