OSI PHARMACEUTICALS ANNOUNCES SUBMISSION OF NEW DRUG APPLICATION FOR TARCEVA IN JAPAN

OSI Pharmaceuticals has submitted a new drug application in Japan covering the use of Tarceva (erlotinib), for the treatment of advanced or recurrent non-small cell lung cancer (NSCLC).

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.