Tarceva erlotinib regulatory update

Astellas submitted an sNDA to FDA to expand the label of Tarceva erlotinib to include first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations as detected by an approved test. Astellas said the cobas EGFR Mutation Test from partner Roche is already under review by the agency as a companion diagnostic. The real-time PCR-based test, which detects 41 mutations across exons 18, 19, 20 and 21 of the EGFR gene, is approved in Europe as a companion diagnostic for Tarceva (see BioCentury, Dec. 12, 2011). ...