Advanced prostate cancer drug approved by the FDA
Advanced prostate cancer drug approved by the FDA
10 Sep 2014
The US FDA has approved the oral drug enzalutamide (trade name: Xtandi), for treating advanced prostate cancer in men who have not yet received chemotherapy.
The drug originally gained U.S. approval in 2012 for use in patients with castration-resistant prostate cancer that has spread beyond the prostate only after they had first received chemotherapy treatment.
Risk of death reduced by 29% compared to a placebo
The additional approval was based on results of a Phase 3 trial in which Xtandi demonstrated an overall survival benefit, reducing the risk of death by 29% compared with a placebo.
It also significantly reduced the risk of disease progression, delayed the need for chemotherapy and delayed skeletal problems in cancer that had spread to the bones.
Source: Reuters