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news.The European Commission has granted marketing authorization for Sanofi-aventis' Jevtana (cabazitaxel) in conjunction with prednisone/prednisolone to treat the patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen.
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The EU’s decision was based on the positive results from a Phase III TROPIC clinical study that involved 755 patients with mHRPC previously treated with a docetaxel-containing treatment regimen.
The results of the trial demonstrated that 30% reduction in risk of death from mHRPC among patients taking Jevtana in conjunction with prednisone or prednisolone, in comparison to chemotherapy regimen consisting of a standard dose of mitoxantrone and prednisone or prednisolone.
Sanofi-aventis Global Oncology Division senior vice president and head Debasish Roychowdhury said Jevtana in combination with prednisone/prednisolone reduced the risk of death by nearly one third and extended progression-free survival compared to mitoxantrone, an active comparator.