OSI Submits NDA for Tarceva in Japan

OSI Pharmaceuticals, Inc. has submitted an NDA in Japan covering the use of Tarceva for the treatment of advanced or recurrent non-small cell lung cancer (NSCLC). The application was submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) by Chugai Pharmaceutical, Co., Ltd., a Japanese affiliate to Roche and OSI’s international partner for Tarceva. Tarceva is currently approved in the U.S., the EU, 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.

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.