Roche, Pleasanton, Calif, announced FDA approval of expanded claims for the cobas EGFR Mutation Test v2 as a companion diagnostic (CDx) for a broad group of therapies in the treatment of non-small cell lung cancer (NSCLC). This claim expansion allows the test to be used as a CDx for all five currently FDA-approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies targeting EGFR mutations L858R and Exon 19 Deletions in accordance with the approved therapeutic product labeling. The group claim will also enable the test to be used as a CDx for any future approved EGFR TKI therapies targeting the same mutations, without the need to conduct individual clinical studies with the test for each new therapy.
“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,” says Neil Gunn, Head of Roche Sequencing Solutions. “By approving a single test for a broad group of therapies, this new and innovative approach by the FDA1 can pave the way for future EGFR TKI therapies to utilise the cobas EGFR Mutation Test v2 to help identify patients for personalised medicine.”
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/developing-and-labeling-vitro-companion-diagnostic-devices-specific-group-oncology-therapeutic 10 August 2020