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October 2, 2016

FDA permits TAGRISSO blood-based T790M companion diagnostic test

The US Food and Drug Administration (FDA) has granted approval for the blood-based companion diagnostic test for TAGRISSO (osimertinib).

The US Food and Drug Administration (FDA) has granted approval for the blood-based companion diagnostic test for TAGRISSO (osimertinib).

Roche-developed, cobas EGFR Mutation Test v2 examines either a tissue or a blood sample to confirm the presence of a T790M mutation in patients exhibiting metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), which has progressed on or after administration of an EGFR tyrosine kinase inhibitor (TKI) medicine.

It serves as a non-invasive option suitable for NSCLC patients who may not be suitable for biopsy procedures.

"This development offers an important option for the identification of the T790M mutation in patients with metastatic EGFR mutation-positive NSCLC."

Patients testing negative for the T790M mutation with blood-based test are made to undergo the tissue-based testing to confirm the presence of EGFR T790M mutation.

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.

"Delivering targeted therapies, such as TAGRISSO, to the right patients at the right time demonstrates our commitment to testing and quality companion diagnostics."

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