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FDA approves companion diagnostic test for Tagrisso in NSCLC

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The FDA approved a blood-based companion diagnostic for osimertinib for use in certain patients with non–small cell lung cancer, according to the drug’s manufacturer.

The cobas EGFR Mutation Test v2 (Roche Molecular Systems) — a validated companion diagnostic for osimertinib (Tagrisso, AstraZeneca), an epidermal growth factor receptor tyrosine kinase inhibitor — uses either a blood sample or tissue to confirm the presence of a T790M mutation in patients with metastatic EGFR–positive NSCLC who progressed during or after treatment with an EGFR TKI.

Approximately two-thirds of patients who progress with first-generation EGFR TKIs do so because of acquired EGFR T790M mutations, according to an AstraZeneca-issued press release. Osimertinib received FDA approval in 2015 for treatment of patients with metastatic EGFR T790M mutation–positive NSCLC who progressed despite treatment with an EGFR TKI.

“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,” Balazs Halmos, MD, of Montefiore Medical Park at Albert Einstein College of Medicine, said in the press release.

Blood-based testing for an EGFR T790M mutation is recommended only when a tumor biopsy cannot be obtained, according to the press release. Patients who test negative for the mutation on the blood-based test are encouraged, along with their physicians, to re-assess the possibility of using a tissue-based test to confirm the presence of the mutation.

“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,” Andrew Coop, vice president of U.S. medical affairs for oncology at AstraZeneca, said in the press release. “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.”