Chugai submits Japan NDA for OSI's Tarceva

USA-based OSI Pharmaceuticals has submitted a New Drug Application in Japan covering the use of its flagship product, Tarceva (erlotinib), for the treatment of advanced or recurrent non-small cell lung cancer.

The application was submitted to the Japanese Ministry of Health, Labor and Welfare by Chugai, the Japanese subsidiary of Roche, OSI's international partner for the cancer drug, which is currently approved in the USA, 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.

Gabriel Leung, president of OSI Oncology said he expects 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 disease after failure of at least one prior chemotherapy regimen.