Aventis, part of the sanofi-aventis Group announced today that the European Commission has approved Taxotere (docetaxel) Injection Concentrate for use in combination with prednisone as a treatment for men with androgen-independent (hormone- refractory) metastatic prostate cancer.
The Commission approval is based on the results of a large landmark phase III clinical trial, TAX 327, which demonstrated that a Taxotere-based regimen significantly reduced the risk of death by 24 percent in men with androgen- independent (hormone-refractory) metastatic prostate cancer. Investigators in the TAX 327 trial also reported that Taxotere significantly improved patients' Prostate Specific Antigen (PSA) response by 43 percent and improved pain response by 59 percent, relative to mitoxantrone.
In the TAX 327 trial, investigators reported that Taxotere was well tolerated. The most commonly observed adverse events in TAX 327 were alopecia, fatigue and nausea. Grade 3-4 neutropenia was reported more frequently in the Taxotere group than the mitoxantrone group (32 percent vs 21.7 percent, p=0.004).
The results of this pivotal study were presented in June 2004 at the American Society of Clinical Oncology meeting (ASCO). On May 19, 2004, the U.S. Food and Drug Administration granted Taxotere approval for use in combination with prednisone as a treatment for men with hormone-refractory metastatic prostate cancer.