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FDA Panel To Review OSI Pharma's Tarceva As First-line Maintenance Therapy In Advanced Non-small Cell Lung Cancer

OSI Pharmaceuticals Inc. (OSIP) said that the FDA's advisory committee will review the use of Tarceva as a first-line maintenance therapy for patients with advanced non-small cell lung cancer who have not progressed following first-line treatment with platinum-based chemotherapy at its December 16 meeting.

Tarceva is the only oral, non-chemotherapy agent shown to provide a statistically significant improvement in both progression-free survival and overall survival in the NSCLC maintenance setting.

The FDA Prescription Drug Fee Act review date for the Tarceva application is on or about January 18, 2010.

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