TARCEVA GRANTED APPROVAL IN THE EU

OSI Pharmaceuticals has reported that its international partner for Tarceva (erlotinib), Roche, received approval from the European Commission of Tarceva 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, and is approved in the U.S., Canada, and Switzerland. Tarceva is the only epidermal growth factor receptor (EGFR) therapy to demonstrate in a Phase III trial an increase in survival for advanced NSCLC patients.

The European Commission approved Tarceva for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in lung cancer patients with EGFR-negative tumors.

The approval is based on data from a pivotal Phase III study, Trial BR.21, which was recently published in The New England Journal of Medicine. The study compared Tarceva to placebo for the treatment of patients with advanced NSCLC, following failure of first- or second-line chemotherapy.