Roche's (RHHBY) Expanded Label for cobas EGFR Mutation Test v2 Receives FDA Approval

September 29, 2016 6:12 AM EDT

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Roche (OTC, RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved a label extension of the cobas EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Zeneca's non-small cell lung cancer (NSCLC) therapy TAGRISSO™ (osimertinib).

"The label extension for the cobas® EGFR Mutation Test v2 to include another TKI (tyrosine-kinase inhibitor) therapy shows our continued commitment to helping healthcare providers make the best diagnosis for their NSCLC patients at multiple stages of their treatment pathway," said Uwe Oberlaender, Head of Roche Molecular Diagnostics.

On June 1st, 2016, the FDA granted approval of the cobas® EGFR Mutation Test v2, making it the first FDA-approved liquid biopsy test for use in clinical decisions. The test is the only companion diagnostic that is FDA-approved for the detection of the epidermal growth factor receptor (EGFR) gene in DNA derived from plasma or tumor tissue. NSCLC patients who have EGFR exon 19 deletions or L858R mutations are candidates for the EGFR-targeted therapy Tarceva® (erlotinib), in first-line treatment, and patients who have the resistance mutation T790M are candidates for TAGRISSO™ in subsequent lines of treatment.

Current clinical guidelines, including those from the National Comprehensive Cancer Network (NCCN) in the U.S., and the European Society for Medical Oncology (ESMO), recommend EGFR mutation testing in patients with advanced NSCLC, prior to administering targeted therapies.

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