Roche's Tarceva Oked in EU for first-line use in a genetically distinct type of lung cancer

Swiss drug major Roche (ROG: SIX) says that the European Commission has approved Tarceva (erlotinib) for use in patients with a genetically distinct type of non-small cell lung cancer (NSCLC) in Europe.

This approval will enable the use of Tarceva as a first-line monotherapy in people with locally advanced or metastatic NSCLC with EGFR (epidermal growth factor receptor) activating mutations. Tumors with these mutations are responsive to Tarceva and treatment with this drug has been shown to more than triple the number of patients whose tumors shrink (response rate). Tarceva has also shown to nearly double the time patients live without their disease progressing (progression free survival - PFS) compared to chemotherapy.

Tarceva is already approved in Europe for use in advanced or metastatic NSCLC irrespective of a patient’s EGFR status both as maintenance therapy in patients with stable disease immediately after initial chemotherapy and in patients whose disease has progressed following at least one course of chemotherapy. The drug generated sales of 614 million Swiss francs ($757.3 million) in the first half of 2011.