OSI Pharmaceuticals files NDA for Tarceva in Japan

By Elaine Rigoli

Tampa, Fla., April 17 - OSI Pharmaceuticals, Inc. announced Monday that a New Drug Application has been submitted in Japan covering the use of Tarceva (erlotinib) for the treatment of advanced or recurrent non-small cell lung cancer.

The application was submitted to the Japanese Ministry of Health, Labour and Welfare by Chugai Pharmaceutical Co., Ltd., a Japanese affiliate to Roche, OSI's international partner for Tarceva.

Tarceva is approved in the United States, the European Union and about 50 countries worldwide for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen, according to a news release.

The filing is based on results of a phase 2 study that confirmed the safety and efficacy of Tarceva for Japanese patients, along with the data from the non-small cell lung cancer study BR.21, which compared Tarceva to a placebo for the treatment of patients with advanced non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

In November 2005, the Food and Drug Administration approved Tarceva in combination with gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received previous chemotherapy.

Based in Melville, N.Y., OSI Pharmaceuticals develops novel pharmaceutical products for patients with cancer, eye diseases and diabetes.

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