BRIDGEWATER, N.J., Oct. 1 /PRNewswire-FirstCall/ —
Sanofi-aventis (EURONEXT: SAN and NYSE:
SNY) announced today that data from the Phase III TROPIC study,
which was the basis for the June 2010 U.S. Food and Drug
Administration (FDA) approval of Jevtana® (cabazitaxel)
Injection, was published in the October 2, 2010 print edition 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.” 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 a docetaxel-containing
treatment regimen.
“Jevtana is the first approved therapy to fill a critical gap
among patients with the most advanced stage of prostate cancer and
is the first therapeutic option for these patients shown to prolong
survival,” said Oliver Sartor, M.D., Piltz
Professor for Cancer Research at Tulane Medical School, New
Orleans, and North American principal investigator for the pivotal
TROPIC trial.
“Sanofi-aventis Oncology is tackling cancer on all fronts to
provide new solutions that make a difference in patients’
lives,” said Debasish Roychowdhury, M.D., Senior Vice
President, Head of Global Oncology, sanofi-aventis. “The
publication of this pivotal trial in The Lancet underscores
the importance of the study, which is the first to demonstrate an
overall survival advantage in patients with metastatic
hormone refractory prostate cancer whose disease has progressed
following treatment with a docetaxel-containing treatment
regimen.”
Results of the TROPIC study showed that the
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