Roche's innovative cancer drug Tarceva (erlotinib) has received approval by the Swiss health authority Swissmedic for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva is an oral tablet indicated for daily administration.

Roche filed for approval with the Swissmedic in September 2004, with a fast track procedure granted by Swissmedic. The Swiss approval is based on data from a pivotal Phase III study which compared Tarceva to placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy. Patients receiving Tarceva showed an increase in median survival by 42% compared to those in the placebo arm (6.7 months vs. 4.7 months), an improvement of 2 months.

Tarceva was first approved in the United States in November 2004, after priority review, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.

William M. Burns, CEO of Roche's Pharmaceuticals Division said, "Tarceva is the first medicine in its class with a proven survival and without some of the unpleasant side effects of chemotherapy."

"Tarceva is a significant addition to our arsenal of treatments for patients with advanced NSCLC." Dr. Miklos Pless from University Hospital Basel said adding, "There are currently very few treatment options for these patients, but we are now able to offer them the chance of extending their survival without the side effects associated with chemotherapy."

Tarceva is an investigational small molecule that targets the human epidermal growth factor receptor (HER1) pathway. HER1, also known as EGFR, is a key component of this signalling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva blocks tumour cell growth by inhibiting the tyrosine kinase activity of the HER1 signalling pathway inside the cell.