Monday, November 19, 2012

Astellas seeks approval for Tarceva as first line EGFR +ve NSCLC therapy in the US

The sNDA submission is based on results of the international EURTAC trial, a prospective, randomized, controlled Phase 3 trial evaluating the first-line use of Tarceva versus platinum-based chemotherapy in patients with EGFR activating mutation-positive advanced NSCLC.   In the EURTAC trial Tarceva was associated with a median PFS of 10.4 months versus  5.1 months in the platinum-based chemotherapy group. Tarceva reduced the risk of lung cancer getting worse by 66 percent.

A companion diagnostic, the cobas® EGFR Mutation Test developed by Roche Molecular Diagnostics, to identify people with NSCLC whose tumors have EGFR activating mutations is currently under review by the Center for Devices and Radiological Health (CDRH) to support the EURTAC sNDA. It is estimated that as many as one in ten (10 percent) people in Western populations with lung cancer and three in ten (30 percent) Asian people with lung cancer have EGFR activating mutations

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