Roche Holding AG (RHHBY) Thursday said it has submitted the cobas EGFR Mutation Test v2 for Premarket Approval or PMA to the U.S. Food and Drug Administration, as a companion diagnostic test for AZD9291, an AstraZeneca investigational therapy for non-small cell lung cancer patients with an acquired resistant mutation.
Patients with non-small cell lung cancer who have adenocarcinoma with tumor containing an EGFR sensitizing mutation show significant benefit from currently available EGFR TKI therapies.
However, approximately two-thirds of these patients will relapse and develop drug resistance. Roche said that in many cases, this resistance is caused by an acquired mutation called T790M.
The cobas EGFR v2 test can aid clinicians to appropriately select NSCLC patients who have acquired the T790M mutation and are most likely to benefit from AstraZeneca's novel therapy.
For comments and feedback contact: editorial@rttnews.com
Business News