EC Clears Roche’s Tarceva as Monotherapy Against Metastatic NSCLC with EGFR Mutations

Firm projects filing for similar approval of EGFR inhibitor in the U.S. next year.

The European Commission has approved Roche’s EGFR-inhibitor Tarceva® (erlotinib) as first-line monotherapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations. The firm’s Molecular Systems division is currently developing a cobas EGFR mutation test as a companion diagnostic for Tarceva, which it projects will be CE marked during the second half of 2011.

Tarceva is currently approved in Europe for treating advanced or metastatic NSCLC, irrespective of EGFR mutation status, as maintenance therapy either in patients with stable disease after initial chemotherapy or in those whose disease has progressed following at least one course of chemotherapy.

European approval of the drug as first-line monotherapy for EGFR mutation-carrying NSCLC was based on data from the Phase III EURTAC study, which showed that compared with chemotherapy, first-line treatment of EGFR activating mutation-positive NSCLC with Tarceva nearly doubled median progression-free survival to 9.7 months, and more than tripled response rate to 58%. Development of the drug as monotherapy for the EGFR-positive NSCLC indication is ongoing in the U.S., and Roche projects filing for approval for this indication in 2012.

Tarceva was Roche’s seventh top-selling pharmaceutical in the first half of 2011 (to June 30), and achieved global sales of CHF 614 million (about $749 million), up 4% on equivalent 2010 figures.