FDA Approval for TaxotereŽ in Prostate Cancer
21 May 2004
Aventis announced that the US Food and Drug Administration (FDA) has approved TaxotereŽ (docetaxel) Injection Concentrate for use in combination with prednisone as a treatment for men with androgen-independent (hormone-refractory) metastatic prostate cancer.
The FDA approval is based on the final results of a landmark phase III clinical trial that met its primary endpoint of increasing survival in this patient population. The pivotal study, TAX 327, along with an additional study of Taxotere in this patient population, has been selected for presentation at the Plenary Session at the American Society of Clinical Oncology (ASCO) annual meeting on Monday, June 7, in New Orleans, LA. A regulatory submission for Taxotere in prostate cancer is also pending with the European Agency for the Evaluation of Medicinal Products (EMEA).
Article: http://www.medicalnewstoday.com/index.php?newsid=8553