FDA approves Tarceva (Genentech/Astellas) for NSCLC as detected by cobas EGFR Mutation Test

Genentech, and Astellas Pharma US, Inc. have announced that the 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 study. In the study, treatment with Tarceva demonstrated that patients lived longer without their disease getting worse (median progression-free survival [PFS] 10.4 months vs. 5.2 months; HR=0.34; p<0.001 95 percent ci 0.23 to 0.49 compared to chemotherapy. the safety profile for tarceva in the eurtac study was consistent with previous studies of tarceva in nsclc.>