Taxotere gets priority Japan review for mHRPC

French drug major Sanofi-Aventis' cancer drug Taxotere (docetaxel) is under priority review by Japan's Ministry of Health, Labor and Welfare as a treatment for hormone refractory prostate cancer (mHRPC). A supplemental New Drug Application was filed in February.

Since being approved in 2004 in the USA and Europe, Taxotere, in combination with prednisone, has become the standard treatment for mHRPC. In large overseas clinical studies, Taxotere-based regimens have conferred longer survival and improved quality of life compared to other active regimens. However, Sanofi noted that, currently, there are a limited number of drugs for mHRPC with health insurance coverage in Japan. For that reason, Japanese urologists requested that Japan's Society of Clinical Oncology, the Japanese Urological Association and the Japanese Society of Medical Oncology solicit the MHLW to perform a fast review for Taxotere in the prostate cancer indication.

In Japan, Taxotere is used as a therapy for seven types of cancer. The agent has been approved for the treatment of breast cancer and non-small cell lung cancer as the first taxoid antitumor agent in 1996. Furthermore, it obtained approval for gastric, head and neck, and ovarian cancers in 2000 followed by esophageal cancer in 2004 and endometrial cancer in 2005.