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news.Tarceva to treat patients with advanced non-small cell lung cancer
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OSI and Genentech has reported that Saturn, a pivotal phase III study of Tarceva (erlotinib), showed positive results. It showed an overall survival in patients with advanced non-small cell lung cancer (NSCLC), who received Tarceva immediately after initial chemotherapy.
The company said that the overall survival data will be submitted to the FDA and EMEA to support the supplemental New Drug Application (sNDA). The application is for use of Tarceva as a first-line maintenance treatment for patients with advanced NSCLC. It is also to support the application for use of Tarceva as a first-line maintenance treatment submitted in March 2009.
Saturn met its primary endpoint and showed patients with advanced NSCLC (who received Tarceva as a first-line maintenance treatment) had a 41% improvement without the disease advancing, as compared to placebo.
The safety results were consistent with what has been seen previously and there were no new or unexpected safety signals in the study, said the company.