Roche announced today that the European Commission has approved Tarceva® (erlotinib) as monotherapy for maintenance treatment in patients with advanced non-small cell lung cancer (NSCLC) whose disease remains largely unchanged (known as ‘stable disease’) after platinum-based initial chemotherapy. 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 (11.9 months vs. 9.6 months.) 

Patients with advanced NSCLC whose tumours remain largely unchanged after initial chemotherapy (‘stable disease’) have tumours that progress faster, are more resistant to further lines of chemotherapy and have a poorer prognosis compared to patients with a complete or partial response to initial chemotherapy. When entering the pivotal SATURN study approximately half of patients randomised after initial chemotherapy had stable disease.

“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,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. “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. Tarceva also recently gained approval from the U.S. Food and Drug Administration (FDA) for maintenance treatment of NSCLC