FDA Approves New Prostate Cancer Medication Xtandi

By Amir Khan on September 4, 2012 10:34 AM EDT

Prostate Cancer
Micrograph of prostate cancer (Photo: Creative Commons)

The U.S. Food and Drug Administration has approved a new prostate drug developed by Medivation Inc. The drug, known as Xtandi, is intended for patients who have not responded to hormone and chemotherapy treatment.

The approval came three months earlier than the FDA's November-deadline, and caused shares of Medivation Inc. to shoot up 7.6 percent.

The drug is part of a new class of drugs known as androgen inhibitors, which are designed to block testosterone, which fuels cancer cell growth, from binding to prostate cancer cells.

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Aside from skin cancer, prostate cancer is the most common cancer in American men -- more than 250,000 men will be diagnosed with the condition in 2012, according to the American Cancer Society. Most men diagnosed don't die from prostate cancer and treatment side effects are so common doctors often advise men with slow-growing tumors not to undergo treatment, according to the study.

Prostate cancer is typically treated with tumor-removing surgery or radiation, but about 90 percent of men who undergo prostate cancer treatments experience sexual dysfunction and 30 percent have urinary incontinence, according to the American Cancer Society.

"The need for additional treatment options for advanced prostate cancer continues to be important for patients," Richard Pazdur, director of hematology and oncology products at the FDA's drug evaluation and research center, said, according to Reuters. "Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient's life."

The most common side effects from Xtandi were weakness, fatigue and back pain. Less than one percent of patients experienced seizures from the medication and had to be taken off the therapy. The FDA is requiring Medivation to conduct post-approval trials to further examine the risk of seizures.

Medivation said they will begin selling the drug in September for $7,450 for a 30 day supply. Patients were typically on the drug for 8 months.

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