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FDA Expands Label for Roche Cobas EGFR Companion Diagnostic

NEW YORK (GenomeWeb) – The US Food and Drug Administration has expanded the labeling for Roche's Cobas EGFR Mutation Test v2 as a companion diagnostic that can analyze plasma samples from non-small cell lung cancer patients considering treatment with AstraZeneca's Tagrisso (osimertinib). 

The agency approved Tagrisso almost a year ago for advanced NSCLC patients who have acquired the EGFR T790M resistance mutation and progressed despite treatment with other EGFR tyrosine kinase inhibitors. Nearly two-thirds of patients progress on first-generation tyrosine kinase inhibitors due to acquiring a T790M mutation.  

The FDA approved the drug alongside the tissue-based Cobas EGFR Mutation Test v2, which had been updated to detect the T790M mutation in addition to other clinically relevant EGFR mutations detected by the first version of the test. 

Then, in June, the agency approved the PCR-based Cobas EGFR Mutation Test v2 for the detection of EGFR exon 19 deletions or L858R mutations in blood samples when NSCLC patients are considering treatment with Genentech's Tarceva (erlotinib), making it the first and only FDA-approved companion test that can gauge EGFR mutations in tissue and plasma samples. 

"If such mutations are not detected in the blood, then a tumor biopsy should be performed to determine if the NSCLC mutations are present," the FDA said in approving the test in June. "Insofar as the test provides positive results, it may benefit patients who may be too ill or are otherwise unable to provide a tumor specimen for EGFR testing."

NSCLC patients who have EGFR exon 19 deletions or L858R mutations can receive Tarceva as a first-line option, and those with the T790M resistance mutation can receive Tagrisso in later lines of treatment. The latest approval for the Cobas test expands its use as a blood-based test with Tagrisso.

"The label extension for the Cobas EGFR Mutation Test v2 to include another TKI therapy shows our continued commitment to helping healthcare providers make the best diagnosis for their NSCLC patients at multiple stages of their treatment pathway," Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a statement.

AstraZeneca said in a statement that the Cobas EGFR Mutation Test v2 is available through Baystate Health, Carolinas HealthCare System, Laboratory Corporation of America, and PhenoPath.