AstraZeneca's (AZN) TAGRISSO T790M Companion Diagnostic Test Approved by U.S. FDA
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US FDA Approves TAGRISSO® (osimertinib) Blood-Based T790M Companion Diagnostic Test
September 29, 2016 7:00 AM EDTWILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a blood-based companion diagnostic for TAGRISSO® (osimertinib). The companion diagnostic for TAGRISSO is the only FDA-approved and clinically validated companion diagnostic test that uses either tissue or a blood sample to confirm the presence of a T790M mutation in patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after an EGFR tyrosine kinase inhibitor (TKI) medicine.
The approval provides a new, non-invasive option to identify patients with metastatic... More
