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WASHINGTON -- The FDA has approved the androgen receptor-signaling inhibitor enzalutamide (Xtandi) for treatment of castration-resistant prostate cancer (CRPC).

Entered into the FDA's priority review program, enzalutamide received an indication for men who have progressed following treatment with docetaxel.

"The need for additional treatment options for advanced prostate cancer continues to be important for patients," Richard Pazdur, MD, director of the FDA Office of Hematology and Oncology Products, said in a statement. "Xtandi is the latest treatment for this drug to demonstrate its ability to extend a patient's life."

Pazdur's comments alluded to sipuleucel-T (Provenge), cabazitaxel (Jevtana), and abiraterone (Zytiga), all of which have received FDA approval for CRPC since 2010.

As reported earlier this month, a large randomized clinical trial showed a 5-month improvement in overall survival in men with CRPC treated with enzalutamide versus placebo. The findings validated results presented in June at the American Society of Clinical Oncology meeting.

The most commonly reported side effects associated with enzalutamide included weakness or fatigue, back pain, diarrhea, arthralgia, hot flushes, edema, myalgia, headache, upper respiratory infections, dizziness, spinal cord compression, muscle weakness, anxiety, uremia, anxiety, high blood pressure, and tingling sensations.

Enzalutamide is a new-generation anti-androgen that disrupts androgen-receptor signaling at multiple points in the signaling pathway. In contrast to conventional androgen antagonists, enzalutamide has no agonistic effects on the androgen receptor.

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