OSI Pharmaceuticals Announces Submission of New Drug Application for Tarceva(R) in Japan
OSI Pharmaceuticals, Inc. announced that a New Drug Application has been submitted in Japan covering the use of its flagship product, Tarceva(R) (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.
"We applaud our colleagues at Chugai and Roche for their commitment to bringing this important treatment option to lung cancer patients in Japan as quickly as possible," said Gabriel Leung, President, OSI Oncology. "We expect Japan to be among the top countries in terms of sales potential for Tarceva, and to be a key growth driver for this product."
The filing is based on results of a Phase II study that confirmed the safety and efficacy of Tarceva for Japanese patients, along with the data from the NSCLC study BR.21, which compared Tarceva to placebo for the treatment of patients with advanced NSCLC after failure of at least one prior chemotherapy regimen.
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