FDA Approves T790M Companion Diagnostic Test for Osimertinib

The U.S. Food and Drug Administration (FDA) has approved a companion diagnostic test for osimertinib (Tagrisso), which uses either tissue or a blood sample to confirm the presence of a T790M mutation among patients with metastatic EGFR-mutant non-small cell lung cancer (NSCLC) who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.¹

The non-invasive companion diagnostic, cobas EGFR Mutation Test v2, allows for rapid identification of patients who have the T790M mutation at the time of disease progression, and may affect treatment decision-making.

Approximately two-thirds of cases of disease progression on or after first-generation EGFR TKIs are due to an acquired EGFR T790M mutation. Until the accelerated approval of osimertinib in November 2015, limited treatment options were available for these patients.

Osimertinib is the only FDA-approved targeted agent for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC in this setting. Continued approval for this indication may be contingent upon verification of clinical benefit in additional clinical trials.                       

Reference

1. US FDA approves Tagrisso (osimertinib) blood-based T790M companion diagnostic test. AstraZeneca website. https://www.astrazeneca-us.com/content/az-us/media/press-releases/2016/us-fda-approves-tagrisso-osimertinib-blood-based-t790m-companion-diagnostic-test-09292016.html. Updated September 29, 2016. Accessed September 30, 2016.