Saturday, July 23, 2011

Zytiga gets European nod for advanced prostate cancer

A European panel recommended approval of Zytiga an oral drug that has been shown to extend survival in men with advanced prostate cancer. The European Committee for Medicinal Products is expected to approve the drug for sale in the next three months.

The drug approved by the U.S. FDA last April works by blocking the production of an enzyme required for the production of androgen hormones in the adrenal glands, the testes and by prostate tumors themselves. 

In a large clinical trial conducted in 147 centers in 13 countries, researchers compared survival outcomes in patients with prostate cancer that had spread to other parts of the body, and did not respond to treatment that reduced testosterone levels below castration levels. A total of 1,195 men received Zytiga plus standard steroid therapy with prednisone or prednisolone, 797 men had received prednisone or prednisolone with a placebo.

After a median of 13 months, patients who received Zytiga and prednisone/prednisolone combination survived a median of 14.8 months compared to 10.9 months for patients receiving the placebo and prednisone. That study was stopped early so that those receiving placebo could begin taking Zytiga.

Men with advanced metastatic prostate cancer that no longer responds to current hormone blockade therapies have few treatment options, so the approval of Zytiga is a welcome addition to the arsenal drugs available to slow prostate cancer progression.

The most commonly reported side effects in patients receiving Zytiga included joint swelling or discomfort, low levels of potassium in the blood, fluid retention (usually of the legs and feet). Some men experienced muscle discomfort, hot flashes, diarrhea, urinary tract infection, cough, high blood pressure. Other side effects included heartbeat disorders, urinary frequency, increased nighttime urination, upset stomach or indigestion and upper respiratory tract infection.

The drug was developed by British scientists at the Institute of Cancer Research, and has been brought to market by Centocor Ortho Biotech.

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