FDA OK's Tarceva in 1st-line NSCLC with cobas EGFR Dx
This article was originally published in Scrip
Executive Summary
With the FDA's approval of Roche Molecular Diagnostics' cobas EGFR Mutation test on 14 May, the agency also cleared the way for Genentech and Astellas to market Tarceva (erlotinib) as a first-line therapy for patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) activating mutations, as detected by the new diagnostic.