FDA OKs New Drug for Advanced Prostate Cancer

Jevtana Can Be Used for Treatment When Other Therapies No Longer Work

By Kathleen Doheny
WebMD Health News

Reviewed By Laura J. Martin, MD

June 17, 2010 -- A new treatment for advanced prostate cancer that hasn't responded to other treatments has been approved by the FDA.

Called Jevtana (cabazitaxel), the chemotherapy drug is used in combination with the steroid prednisone and has been found to lengthen survival by nearly 2 and 1/2 months in men who have run out of treatment options.

The drug, made by Sanofi-aventis, got priority review under an FDA program which offers an expedited six-month review for drugs that could offer major advances in treatment or provide an effective treatment when no other adequate one exists.

The approval is for use in advanced, hormone-refractory prostate cancer which has worsened despite treatment with a regimen including the drug docetaxel.

An estimated 192,280 new cases of prostate cancer were diagnosed in 2009 in the U.S., according to American Cancer Society, with an estimated 27,300 deaths.

The Jevtana approval is based on a study involving 755 patients who had previously received the docetaxel regimen. Researchers compared the overall survival in those on Jevtana plus prednisone with those who got another chemo drug, mitoxantrone, with prednisone.

Those on the Jevtana regimen had a median overall survival of 15.1 months (half lived longer, half less) or about a year and three months, compared to 12.7 months, about a year, on the comparison regimen.

The new treatment is not without side effects. Among them are a decline in white blood cells, anemia, low platelet counts, fatigue, nausea, vomiting, infections, and kidney failure.

Even so, the differences in survival were significant, according to the researchers.

"This is truly a significant announcement for the prostate cancer community, addressing an unmet medical need," says Oliver Sartor, MD, the principal investigator for the study in North America and a professor at Tulane Medical School in New Orleans, in a statement. Sartor is a consultant and investigator for Sanofi-aventis and some other pharmaceutical companies.

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SOURCES: News release, FDA.

News release, Sanofi-aventis.

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