Roche Gets EC Approval for Tarceva

29 April 2010 (Last Updated April 29th, 2010 18:30)

The European Commission has approved Roche's Tarceva (erlotinib) as a monotherapy for maintenance treatment in patients with advanced non-small cell stable lung cancer (NSCLC) after platinum-based initial chemotherapy. Approval is based on data from the pivotal SATURN study, which shows

The European Commission has approved Roche's Tarceva (erlotinib) as a monotherapy for maintenance treatment in patients with advanced non-small cell stable lung cancer (NSCLC) after platinum-based initial chemotherapy.

Approval is based on data from the pivotal SATURN study, which shows that compared with the placebo, Tarceva gave patients with the 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.

Roche executive vice president and global development and chief medical officer Hal Barron said the approval of Tarceva for maintenance use in stable, advanced non-small cell lung cancer offers patients a much needed additional treatment.

"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," Barron said.

Tarceva has been approved in the EU since September 2005 and in the USA since November 2004 for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.