AstraZeneca announced that the US Food and Drug Administration approved a blood-based companion diagnostic test that can determine whether Astra Zeneca’s Tagrisso can be used a type of non-small-cell lung cancer.
AstraZeneca has about 2,100 employees in Delaware.
The approval provides a new, non-invasive option to identify patients with metastatic EGFR T790M mutation-positive NSCLC, ensuring that those patients who may not be suitable for biopsy procedures have an opportunity to be tested.
Blood-based testing for the presence of the mutation is recommended only when a tumor biopsy cannot be obtained.
The companion diagnostic, cobas® EGFR Mutation Test v2, was developed by Roche Molecular Systems. The test is initially available through Baystate Health, Carolinas HealthCare System, Laboratory Corporation of America Holdings (LabCorp), and PhenoPath.
“Blood-based testing has the potential to rapidly identify patients eligible for targeted therapy, who may not be eligible for biopsy. Availability of this blood-based test may help aid treatment decisions,” said Balazs Halmos, MD, Montefiore Medical Park, Albert Einstein College of Medicine.
“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,” said Andrew Coop, vice president, US Medical Affairs, Oncology, AstraZeneca. “Delivering targeted therapies, such as Tagrisso , to the right patients at the right time demonstrates our commitment to testing and quality companion diagnostics.”
Tagrisso was approved by the FDA in November 2015. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in other trials.
