OSI Pharmaceuticals, Inc. (Nasdaq: OSIP - News) announced today that a New Drug Application has been submitted in Japan covering the use of its flagship product, Tarceva® (erlotinib), for the treatment of advanced or recurrent non-small cell lung cancer (NSCLC). The application was submitted to the Japanese Ministry of Health, Labour and Welfare (MHLW) by Chugai Pharmaceutical, Co., Ltd., a Japanese affiliate to Roche, OSI’s international partner for Tarceva. Tarceva is currently approved in the United States, the European Union, and approximately 50 countries worldwide for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.
