Cobas EGFR Mutation Test regulatory update

FDA approved the cobas EGFR Mutation Test from Roche as a companion diagnostic for cancer drug Tarceva erlotinib. The agency said the test is the first FDA-approved companion diagnostic that detects EGFR mutations. Roche said the test will be available immediately. The real-time PCR-based test, which detects 41 mutations across exons 18, 19, 20 and 21 of the EGFR gene, is approved as a companion diagnostic for Tarceva in Europe, where the drug is approved for first-line treatment in non-small cell lung cancer (NSCLC) patients with EGFR-activating mutations (see BioCentury, Dec. 12, 2011).

FDA also approved an sNDA from Astellas Pharma Inc. (Tokyo:4503, Tokyo, Japan) for Tarceva for first-line treatment in patients with metastatic NSCLC and EGFR-activating mutations. The small molecule inhibitor of EGFR tyrosine kinase activity was already approved in the U.S. for pancreatic cancer for first-line maintenance and second-line treatment of advanced or metastatic NSCLC irrespective of EGFR mutation status. ...