FDA Approves Expanded Use and Companion Diagnostic for Tarceva

The FDA has approved the use of erlotinib (Tarceva) as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. Tarceva, a tyrosine kinase inhibitor (TKI) that inhibits EGFR, had already been approved for patients with advanced NSCLC as a second- or later-line treatment if at least one chemotherapy regimen had failed, or as maintenance treatment if their disease had not progressed after four cycles of chemotherapy. At the same time, the FDA approved, for the first time, a test for EGFR mutations, the cobas EGFR Mutation test. The test enables doctors to identify which patients have EGFR mutations and are therefore candidates for first-line treatment with Tarceva, making it a so-called ‘companion diagnostic’ for Tarceva.