Jevtana (cabazitaxel) Injection Approved
by U.S. FDA After Priority Review
- First and only therapy to provide significant survival benefit
in second-line metastatic hormone-refractory prostate cancer -
Paris, France – June 17, 2010 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the U.S.
Food and Drug Administration (FDA) has granted marketing authorization for Jevtana (cabazitaxel) Injection in
combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer
(mHRPC) previously treated with a docetaxel-containing treatment regimen.
Jevtana, a microtubule inhibitor, in combination with prednisone was approved based on results from the Phase 3
TROPIC clinical study involving 755 patients with mHRPC previously treated with a docetaxel-containing treatment
regimen. Results from this trial demonstrated a statistically significant 30% [HR=0.70 (95% CI: 0.59-0.83); P<0.0001]
reduction in risk of death from mHRPC among patients taking Jevtana in combination with prednisone compared with
an active chemotherapy regimen consisting of a standard dose of mitoxantrone and prednisone. Investigator-assessed
tumor response rates using Response Evaluation Criteria in Solid Tumors (RECIST) were 14.4% and 4.4% for
cabazitaxel-treated and mitoxantrone-treated patients respectively, p=0.0005. No complete responses were observed
on either arm.
“This is truly a significant announcement for the prostate cancer community, addressing an unmet medical need.
With the approval of Jevtana, health care professionals now have a new treatment option for patients with the most
advanced stage of prostate cancer and for whom there have been few options,” said Oliver Sartor, M.D., TROPIC
North American principal investigator, Piltz Professor for Cancer Research at Tulane Medical School, New Orleans.
“Jevtana in combination with prednisone is the only FDA approved regimen to significantly improve overall survival in
patients previously treated with docetaxel