FDA approves androgen inhibitor for metastatic PCa

September 12, 2012

The FDA recently approved the oral androgen receptor inhibitor enzalutamide (Xtandi) for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel (Taxotere).

The FDA recently approved the oral androgen receptor inhibitor enzalutamide (Xtandi) for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel (Taxotere).

The drug is expected to be available to patients in the U.S. in mid-September 2012.

"Enzalutamide provides an exciting new option for physicians that can prolong the lives of patients with metastatic prostate cancer who have received chemotherapy," said Howard I. Scher, MD, of Memorial Sloan-Kettering Cancer Center, New York, co-principal investigator of the phase III AFFIRM pivotal study.

In the study, the safety and effectiveness of enzalutamide was evaluated in 1,199 patients with metastatic castration-resistant prostate cancer who had received prior treatment with docetaxel. The study was designed to measure overall survival in men receiving enzalutamide compared with men receiving a placebo. The median overall survival for patients receiving enzalutamide was 18.4 months, compared with 13.6 months for the patients who received placebo.

The most common side effects observed in study participants taking enzalutamide were weakness or fatigue, back pain, diarrhea, joint pain, hot flush, tissue swelling, musculoskeletal pain, headache, upper respiratory infections, dizziness, spinal cord compression and cauda equina syndrome, muscular weakness, difficulty sleeping, lower respiratory infections, blood in urine, tingling sensation, anxiety, and high blood pressure.

The recommended dose of enzalutamide is 160 mg (four 40-mg capsules) administered orally once daily.

Dr. Scher is a consultant/adviser for Medivation, which is partnering with Astellas Pharma Inc. to make enzalutamide available in the U.S.

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