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news.Sanofi-aventis has published Jevtana (cabazitaxel) Injection Phase III Tropic study results in the 2 October issue of The Lancet in an article titled “Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial.”
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Jevtana, a microtubule inhibitor, is approved in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-based treatment regimen.
The Phase III Tropic study data was the basis for the June 2010 US Food and Drug Administration approval of Jevtana.
Tropic was conducted in 146 trial sites in 26 countries, including the US. The multicenter, Phase III, randomised registrational trial assessed 755 mCRPC patients whose disease had progressed following treatment with docetaxel-based chemotherapy.
The data demonstrated that Jevtana in combination with prednisone reduced the risk of death by 30% in men with metastatic castration-resistant prostate cancer (also known as metastatic hormone refractory prostate cancer, or mHRPC) whose disease progressed following treatment with docetaxel-based chemotherapy.
sanofi-aventis Global Oncology head and senior vice president Debasish Roychowdhury said that the publication of the pivotal trial underscores the importance of the study, which is the first to demonstrate an overall survival advantage in patients with hormone refractory prostate cancer whose disease has progressed following treatment with a docetaxel-containing treatment regimen.