OSI submits Tarceva in Europe and USA

OSI Pharmaceuticals, fellow USA-based Genentech and their European partner Swiss drug major Roche have simulatneously filed a supplemental  New Drug Application to the  Food and Drug Administration and the  European Medicines Agency (EMEA) for the use of Tarceva (erlotinib) as a  first-line maintenance therapy for people with advanced non-small cell  lung cancer who have not progressed following first-line treatment with  platinum-based chemotherapy.

Both submissions are based on a pivotal Phase III placebo-controlled,  randomized, double-blind trial known as SATURN. In November 2008, OSI,  Genentech and Roche announced that SATURN met its primary endpoint and  showed that Tarceva significantly extended the progression-free survival  of patients with advanced NSCLC when given immediately following initial  treatment with platinum-based chemotherapy, compared to placebo. The  SATURN data will be presented at the annual meeting of the American  Society of Clinical Oncology beginning in May. Overall survival data, a  secondary endpoint of the study, are expected in the second half of 2009  and will be part of the FDA review process.

"Tarceva will be the first EGFR-targeted and oral therapy available as a  first-line maintenance treatment for people with NSCLC," said OSI chief  executive Colin Goddard.