OSI Pharmaceuticals Announces Submission of New Drug Application for Tarceva(R) in Japan
"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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