FDA grants Priority Review to Tarceva sNDA

Astellas Pharma Inc. (Tokyo:4503) said FDA accepted and granted Priority Review to an sNDA for Tarceva erlotinib for 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. The company said the PDUFA date is in 2Q13, but the exact date is not disclosed. 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 as a companion diagnostic for Tarceva in Europe, where the drug is already approved for first-line treatment in NSCLC patients with EGFR activating mutations. ...