The approval is based on data from the pivotal SATURN study which showed that compared to placebo Tarceva gave patients with stable disease a 39% improvement in overall survival (OS) and a 2.3 month improvement in median survival.
When entering the pivotal SATURN study approximately half of patients randomised after initial chemotherapy had stable disease.
Hal Barron, executive vice president and global development and chief medical officer, said: “The approval of Tarceva for maintenance use in stable, advanced non-small cell lung cancer offers patients a much needed additional treatment option and reinforces the role that this medicine has to play in treating this devastating disease. Instead of waiting for their disease to progress, patients can now opt to continue to keep it under control, which may help them live longer.”
Tarceva has been approved in the EU since September 2005 and in the US since November 2004 for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.