Molecular Test for Oncology Drug Seeks Premarket Approval

Roche is seeking FDA premarket approval of its companion diagnostic test for AstraZeneca’s investigational therapy for non-small cell lung cancer (NSCLC) patients with an acquired resistant mutation.

NSCLC patients who have adenocarcinoma with tumor containing an EGFR-sensitizing mutation significantly benefit from existing EGFR TKI therapies. However, about two-thirds of these patients will develop treatment resistance, which is often caused by an acquired mutation called T790M.

Roche’s cobas EGFR Mutation Test v2 is designed to help clinicians identify NSCLC with this T790M mutation who are most likely to benefit from AstraZeneca’s novel AZD9291 therapy, which has been granted Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA.

“The collaboration with AstraZeneca to be the companion diagnostic for their third-generation EGFR drug therapy…demonstrates the value of molecular testing in patients,” stated Paul Brown, head of Roche Molecular Diagnostics.