Osi Pharmaceuticals files sNDA for lung cancer drug

Osi Pharmaceuticals, a biotechnology company, and Genentech, have announced that Osi has submitted a supplemental new drug application to the FDA for the use of Tarceva 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.

Additionally, the companies announced that Roche, their international collaborator for Tarceva, filed an application in Europe with the European Medicines Agency.

Both the US and EU submissions are based on a pivotal Phase III placebo-controlled, randomized, double-blind trial known as Saturn. The Saturn data will be reported in June 2009. 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.

Colin Goddard, CEO of Osi Pharmaceuticals, said: If approved, Tarceva will be the first epidermal growth factor receptor targeted and oral therapy available as a first-line maintenance treatment for people with non-small cell lung cancer, which we believe is an important advancement in the treatment of lung cancer.

OSI Pharmaceuticals is focused on discovering, developing and commercializing novel and personalized medicines designed for life of patients with cancer and diabetes/obesity.

Genentech is a biotechnology company that discovers, develops, manufactures and commercializes medicines for patients with significant unmet medical needs.