FDA Approval Alert: Blood-Based Companion Diagnostic to Osimertinib Approved for NSCLC


The US Food and Drug Administration (FDA) has approved a blood-based companion diagnostic for osimertinib (Tagrisso; AstraZeneca), a tyrosine kinase inhibitor (TKI) indicated for the treatment of metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).


Related Content

Blood-Based Diagnostic Test Useful for Detecting Lung Cancer and Other Tumors

FDA approval alert: First blood-based genetic test approved for NSCLC


The companion diagnostic is the only FDA-approved and clinically validated companion diagnostic test that uses either tissue or a blood sample to confirm the presence of T790M mutations within patients with EGFR mutation-positive NSCLC who have progressed on or after treatment with an EGFR TKI therapy.

The approval will provide patients not suitable for biopsy procedures the opportunity to still have their tumors tested for targetable mutations; targeted treatments have been shown to perform better than standard regimens in these patients. However, blood-based testing for the presence of mutations is still only recommended when tumor biopsies cannot be obtained. Additionally, patients who test negative for the T790M mutation with the blood-based test should be reevaluated with tissue-based testing when feasible.

“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,” said Andrew Coop, Vice President, US Medical Affairs, Oncology, AstraZeneca, the company that produces the test. “Delivering targeted therapies, such as Tagrisso, to the right patients at the right time demonstrates our commitment to testing and quality companion diagnostics.”

Currently, osimertinib is the only targeted regimen approved for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after initial treatment with an EGFR TKI therapy.