FDA OKs Drug for Advanced Prostate Cancer

A new drug designed to treat advanced prostate cancer that isn’t responding to other therapies received U.S. Food and Drug Administration approval Friday.

The drug, to be sold as Xtandi (enzalutamide), received expedited approval under FDA’s priority review program for medicines that have the potential to significantly advance current treatment, the agency said.

“The need for additional treatment options for advanced prostate cancer continues to be important for patients,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, said in an agency news release. “Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient’s life.”

Xtandi interferes with production of the male sex hormone testosterone, which stimulates prostate tumors to grow. It is meant for men whose cancer has recurred or spread despite hormone therapy or chemotherapy, the FDA said.

In a study of nearly 1,200 prostate cancer patients, men taking Xtandi had a median overall survival time of 18.4 months, compared to 13.6 months for patients taking a placebo.

Almost 242,000 men will be diagnosed with prostate cancer and more than 28,000 will die from it this year, according to the U.S. National Cancer Institute.

Side effects experienced by study participants included back pain, fatigue or weakness, diarrhea, joint pain, headache, dizziness, and High Blood Pressure. About 1 percent of those taking Xtandi had to discontinue the drug because of seizures, the FDA said.

Xtandi will be marketed by Astellas Pharma U.S. Inc. of Northbrook, Ill., and Medivation Inc. of San Francisco.

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American Cancer Society