French drug major Sanofi (Euronext: SAN) yesterday announced the UK launch of Jevtana (cabazitaxel), in combination with prednisone/prednisolone for the treatment of men with mHRPC previously treated with docetaxel.
Men with this stage of cancer typically have a poor prognosis and until now, there have been no licensed treatments available to extend life. Jevtana is the first licensed agent to significantly extend overall survival in men with mHRPC whose disease has progressed during or after treatment containing docetaxel (15.1 months median overall survival versus 12.7 months in the control arm; HR=0.70 (95% CI: 0.59-0.83); P<0.0001). In clinical trials, Jevtana was also shown to double the median time before the disease progressed compared with mitoxantrone - 2.8 months versus 1.4 months [HR = 0.74 (95% CI: 0.64-0.86); P<0.0001].
The Jevtana launch in the UK follows the grant of marketing authorization from the European Commission in March 2011 for the 27 member states of the European Union, as well as Iceland, Lichtenstein and Norway (The Pharma Letter March 21). The decision to grant marketing authorisation was based on the results from the Phase III TROPIC clinical study involving 755 patients with mHRPC previously treated with docetaxel.
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