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news.OSI Pharmaceuticals has submitted a new drug application in Japan covering the use of Tarceva in advanced or recurrent non-small cell lung cancer.
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The application was submitted to the Japanese Ministry of Health, Labour and Welfare (MHLW) by Chugai Pharmaceutical, a Japanese affiliate to Roche, OSI’s international partner for Tarceva (erlotinib).
Tarceva is currently approved in the US, the European Union, and approximately 50 countries worldwide for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
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.
“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,” commented Gabriel Leung, president of OSI Oncology.