Data published showing survival benefit for sanofi-aventis' prostate cancer drug Jevtana

Late-stage study results that formed the basis of the FDA's decision to approve sanofi-aventis' Jevtana (cabazitaxel) for advanced prostate cancer have been published in The Lancet, the drugmaker announced. The previously released data from the TROPIC trial are "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," noted Debasish Roychowdhury, sanofi-aventis' head of oncology.
In the study, 755 men with advanced prostate cancer were randomised to receive either Jevtana or mitoxantrone, both in combination with prednisone. Results showed that sanofi-aventis' drug reduced the risk of death by 30 percent compared to mitoxantrone, while an improvement in median overall survival of 15.1 months was seen with Jevtana, compared with 12.7 months in the mitoxantrone arm. Further, Jevtana slowed development of the cancer, with median progression-free survival with the drug of 2.8 months, versus 1.4 months for mitoxantrone.
However, the drugmaker noted that 18 percent of patients who received Jevtana discontinued treatment due to adverse events, which included neutropenia and renal failure, compared to 8 percent of those who took mitoxantrone. In addition, the number of deaths not related to disease progression were higher in the group of patients receiving Jevtana, sanofi-aventis said, with 18 deaths, compared to 3 in the mitoxantrone group.
A regulatory application for the drug is currently being reviewed by the European Medicines Agency.

Reference Articles
Prostate cancer drug could provide two precious extra months of life to men in advanced stages of the disease - (Daily Mail)
Sanofi says Jevtana improves prostate cancer survival - (Forexpros)
New chemo offers chance of longer life - (The Scotsman)
Drug extends lives of advanced prostate cancer patients - (The Telegraph)
Jevtana improves survival in advanced prostate cancer patients - (sanofi-aventis)

**Published in "First Word"