FDA expands Tarceva label, approves companion diagnostic

FDA approved an sNDA from Astellas Pharma Inc. (Tokyo:4503) on Tuesday to expand the label for Tarceva erlotinib and also approved the cobas EGFR Mutation Test from partner Roche (SIX:ROG; OTCQX:RHHBY) as a companion diagnostic for the cancer drug. Tarceva is now approved for first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) and EGFR-activating mutations. The small molecule inhibitor of EGFR tyrosine kinase activity was already approved in the U.S. for pancreatic cancer and for first-line maintenance and second-line treatment of advanced or metastatic NSCLC irrespective of EGFR mutation status.

FDA said cobas EGFR Mutation 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 NSCLC patients with EGFR-activating mutations. ...