Astellas seeking to expand U.S. approval for Tarceva

Astellas Pharma Inc. (Tokyo:4503) 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 (SIX:ROG; OTCQX:RHHBY) 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. ...