Anti-Cancer Agent, Herceptin^®
Application for Approval of Additional Indication of Operable Breast Cancer with HER2 Overexpression

Chugai Pharmaceutical Co., Ltd. [Head Office: Chuo-ku, Tokyo; President Osamu Nagayama (hereinafter, Chugai)] announced today that the company filed an application with the Japanese Ministry of Health, Labour and Welfare for the approval of an additional indication of operable breast cancer with HER2 overexpression for humanized anti-human monoclonal antibody, "Herceptin^® Injections 60 and 150" [generic name: trastuzumab (genetical recombination)].

Herceptin^® is a humanized monoclonal antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. It has been approved and sold in more than 90 countries, Herceptin^® is marketed by Chugai in Japan, by Genentech in the US, and by Roche in the rest of the world.  In Japan, it was approved for the indication of "metastatic breast cancer with HER2 overexpression" in April 2001 and was launched in June 2001.

It has been reported that about 25 to 30% of breast cancer patients have HER2 overexpression*, which demands special and immediate attention because tumors of these patients are fast-growing.  Currently, Herceptin^® is widely used as a standard therapy for metastatic breast cancer with HER2 overexpression.

Four large global clinical studies have been performed to confirm the efficacy of postoperative adjuvant therapy with Herceptin^® for early HER2-positive breast cancer.  Japanese medical institutions have participated in one of these global studies, the HERA study.  Chugai made today’s application based on the interim results of HERA study, together with the analysis of the efficacy and safety data of Japanese patients enrolled in the study.

Outside of Japan, the European Medicines Agency and the US Food and Drug Administration approved Herceptin^® for the indication of early-stage HER2-positive breast cancer in May and November 2006, respectively.

*Slamon DJ et al. Science 1989;224(4905):707-12
 
About HERA study
The HERA study, conducted by Roche and Breast International Group (BIG), is one of the largest postoperative adjuvant therapy studies ever carried out among breast cancer patients; enrollment to the trial began in December 2001, and nearly 5,100 HER2-positive patients were enrolled at 480 sites in 39 countries across the world.  The enrollment of patients has been completed in Japanese medical institutions participating in HERA study.

The HERA study is a randomized controlled trial to evaluate efficacy and safety of Herceptin in women with early-stage HER2-positive breast cancer, following standard adjuvant chemotherapy and radiotherapy (if applicable), before or after operation.  Patients were either treated or not treated with Herceptin^® every three weeks for 1 year or 2 years.