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AstraZeneca’s Tagrisso blood-based T790M companion diagnostic test gets FDA approval

MDBR Staff Writer Published 30 September 2016

AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Tagrisso (osimertinib) blood-based T790M companion diagnostic test.

The test 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.

Roche Molecular Systems developed the cobas EGFR Mutation Test v2, which enables identification of patients who have the T790M mutation at disease progression.

It will be initially offered through Baystate Health, Carolinas HealthCare System, Laboratory Corporation of America Holdings and PhenoPath.

Blood-based testing for T790M was carried out in multiple studies, including in a cross-platform comparison of leading technologies to support the clinical development of Tagrisso.

Tagrissi is claimed to be the only FDA-approved targeted medicine for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after an EGFR TKI medicine.

The medicine was approved by the FDA in November 2015.

AstraZeneca oncology US medical affairs vice president Andrew Coop said: “The availability of an FDA-approved, blood-based companion diagnostic is a tremendous step forward for patients with lung cancer in need of a high-quality test that provides results with a rapid turnaround time.

“This development offers an important option for the identification of the T790M mutation in patients with metastatic EGFR mutation-positive NSCLC who have progressed on an EGFR TKI medicine, for whom a tissue biopsy may not be feasible.”