Tarceva, co-developed by Roche, OSI Pharmaceuticals and Genentech, is an oral tablet indicated for daily administration, and is approved in the US, Canada, and Switzerland.
It is the only epidermal growth factor receptor therapy to demonstrate in a phase III trial an increase in survival for advanced non-small cell lung cancer (NSCLC) patients.
The EU approval is based on data from a pivotal phase III study that compared Tarceva to placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy. As with the US, Swiss, and Canadian approvals, no mandatory testing for EGFR is required.
“Despite being the biggest cancer killer, lung cancer is an often neglected disease,” said Dr Giuseppe Giaccone, VU Medical Center, Amsterdam. “Over 50 % of lung cancer patients in Europe are not receiving second-line treatment. With the approval of Tarceva, physicians now have a viable alternative to chemotherapy for their patients.”