Health Canada grants market authorization for Sanofi-aventis Jevtana to treat prostate cancer

JevtanaTM demonstrates higher survival rate among advanced stage prostate cancer patients

Sanofi-aventis announced today that Health Canada has granted market authorization for Jevtana™ (cabazitaxel) injection in combination with prednisone for the treatment of patients with metastatic castration resistant (hormone refractory) prostate cancer (mCRPC), previously treated with a docetaxel-containing treatment regimen.

"Jevtana™ is an effective chemotherapy treatment. It has been approved for patients who have received prior chemotherapy, and provides a significant survival benefit to individuals diagnosed with metastatic castration resistant (hormone-refractory) prostate cancer according to a study published in the Lancet in 2010," said Dr. Fred Saad, Professor and Chair of Urology and Director of G-U Oncology at the University of Montreal Hospital Centre. "The impact of this approval will mean a new line of treatment for advanced stage Canadian prostate cancer patients, offering them a treatment option where there was previously none before."

mCRPC is an advanced form of prostate cancer in which the cancer has continued to grow despite the suppression of male hormones, called androgens, which often fuel the growth of prostate cancer cells. Jevtana™ has been shown to work by causing the intracellular microtubules, which help separate chromosomes into daughter cells during cell division, to stabilize so that the cells can no longer grow or divide.

"Through our continued dedication to research and innovation, sanofi-aventis is committed to working with the oncology community to improve the lives of Canadians affected by prostate cancer," said Stan Glezer, VP Medical, sanofi-aventis Canada Inc. "This approval announcement brings Jevtana™ one step closer to becoming available to advanced stage prostate cancer patients diagnosed with mCRPC, one of the most difficult types of prostate cancer to treat."

Jevtana™ was approved based on results from the Phase III TROPIC (Treatment of Metastatic Hormone-Refractory Prostate Cancer Previously Treated with Taxotere-Containing Regimen) clinical study involving 755 patients with mCRPC previously treated with a docetaxel-containing treatment regimen, the results of which were published in the Lancet.

"Access to a greater range of effective treatment options at all stages of prostate cancer is of great importance to prostate cancer patients," said Steve Jones, President and CEO, Prostate Cancer Canada. "We welcome all advances that will improve the lives of men and their families who are living with this disease."



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