FDA Approves T790M Companion Diagnostic Test for Osimertinib

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The FDA has approved a companion diagnostic test for osimertinib (Tagrisso).
The FDA has approved a companion diagnostic test for osimertinib (Tagrisso).

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.

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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.                       


  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.

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