Sanofi-aventis announced that the Japanese Ministry of Health, Labor and Welfare has granted an approval for use of Taxotere injection in prostate cancer.

A New Drug Application (NDA) was filed on February 28, 2007 and designated as a priority review on May 10, 2007 for the treatment of patients with prostate cancer having progressed or relapsed prostate cancer after surgical or medical castration.

Taxotere is already approved in Japan for the treatment of breast cancer, non-small cell lung, gastric, head and neck, ovarian, esophageal and endometrial cancers.

This new approval is based on the results of an international large-scale phase-III clinical study TAX327 and on a Japanese phase-II clinical trial.

The TAX327 Study demonstrated that Taxotere 75 mg/m² every 3 weeks + prednisone / prednisolone combination therapy significantly increases the overall survival versus mitoxantrone + prednisone (in median: 19.2 months vs. 16.3 months, p=0.004; resulting in a reduction of the risk of death by 21 per cent) and improves quality of life (QOL) compared with mitoxantrone + prednisone. The most commonly observed adverse events were alopecia, fatigue and nausea. Grade 3-4 neutropenia was reported more frequently in the Taxotere group than in the mitoxantrone group (32 percent versus 21.7 percent, p=0.004).

In the Japanese phase-II clinical trial, Taxotere + prednisolone1 combination therapy has demonstrated a safety and clinical benefit profile similar to the one observed in the TAX327 study. The overall tumour response rate was 44.2 per cent and PSA marker response rate was 44.4 per cent.

Since its approval in 2004 in Western countries, Taxotere + prednisone combination has become a standard therapy for the treatment of metastatic Hormono-Resistant Prostate Cancer ( mHRPC).

Currently, there are a limited number of drugs with health insurance coverage, which are effective against prostate cancer in Japan. Taxotere has a unique mode of action different from the existing drugs and is the only chemotherapy which significantly shows the prolongation of overall survival in the patients with mHRPC.

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