FDA approves Tarceva (erlotinib) tablets and Roche cobas EGFR Mutation Test for NSCLC

May 16, 2013

Roche has announced that the U.S. Food and Drug Administration (FDA) has approved Tarceva (erlotinib) tablets for the initial (first-line) treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have certain epidermal growth factor receptor (EGFR) activating mutations as detected by an FDA-approved test. The FDA also approved the cobas EGFR Mutation Test, which was developed by Roche and validated in the pivotal EURTAC (European Randomized Trial of Tarceva vs. Chemotherapy) study. In the study, treatment with Tarceva demonstrated that patients lived longer without their disease getting worse compared to chemotherapy (median progression-free survival; 10.4 months vs. 5.2 months). The safety profile for Tarceva in the EURTAC study was consistent with previous studies of Tarceva in NSCLC.

This latest FDA approval for Tarceva is based on the results of the Phase III EURTAC study, which evaluated the first-line use of Tarceva vs. platinum-based chemotherapy in people with EGFR-activating mutation-positive advanced NSCLC. Tumor shrinkage was observed in 65% of patients with Tarceva and in 16% of people treated with chemotherapy.

In the United States, Tarceva is already approved, irrespective of histology or biomarker status, for people with advanced-stage NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (maintenance treatment). Tarceva is also approved for patients with advanced-stage NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen (second- or third-line treatment). Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC. Learn more about the cobas EGFR Mutation Test.