TARCEVA® (Erlotinib)

TARCEVA® (Erlotinib): The FDA on May 14, 2013 approved TARCEVA® for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. The FDA concurrently approved the cobas EGFR Mutation Test, a companion diagnostic test for detection of these molecular abnormalities. TARCEVA has had prior FDA approval for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen and for maintenance treatment of patients with locally advanced or metastatic NSCLC, whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. TARCEVA® is a product of Astellas Pharma Inc.