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Approval for S-A's prostate cancer drug

Sanofi-aventis has been granted EU approval to market its advanced prostate cancer treatment, Jevtana

Sanofi-aventis (S-A) has been granted EU approval to market its advanced prostate cancer treatment, Jevtana (cabazitaxel).

The drug has been approved in combination with prednisone/prednisolone in patients with metastatic hormone-refractory prostate cancer (mHRPC) who have previously undergone a docetaxel-containing regimen.

Jevtana had previously been given a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) – the European Medicines Agency's (EMA) committee to offer advice on medicines to be used in humans.

It has also been approved for use in the US by the Food and Drug Administration (FDA) in 2010.

Jevtana has shown positive results in the phase III TROPIC study, which involved 755 patients with mHRPC previously treated with a docetaxel-containing treatment regimen.

It found the median survival of patients receiving Jevtana was 15.1 months. This was 2.4 months longer than patients receiving mitoxantrone, a current chemotherapy treatment for prostate cancer.

21st March 2011

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