The US Food and Drug Administration has approved another drug for the treatment of a subset of patients with prostate cancer.
Xtandi (enzalutamide) is now an FDA-approved drug treatment indicated for men with metastatic, castration-resistant prostate cancer that has recurred or spread, regardless of prior therapy to reduce testosterone levels. Ztandi is approved to be administered alongside the chemotherapeutic drug docetaxel.
Xtandi's approval comes three months sooner than expected. It was reviewed under the FDA's speedy Priority Review Program, generally reserved for major breakthroughs in treatment or a therapy that services an unmet need in a patient population.
The trial data that convinced the FDA composed of a randomized phase III trial involving just under 1,200 men. The primary end point of the trial was overall survival, and Xtandi outperformed a placebo by a median overall survival time of 18.4 months compared to 13.6 months.
"The need for additional treatment options for advanced prostate cancer continues to be important for patients," said Dr. Richard Pazdur, the FDA's director of the Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research. "Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient's life."
Source: FDA
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