Today, the US FDA approved Erleada (apalutamide), an androgen receptor inhibitor created by Janssen Pharmaceuticals for the treatment of men with non-metastatic, castration-resistant prostate cancer. Erleada was approved after a priority review of...

New prostate cancer drugs come to market quite rarely because the studies mandated by the FDA cost hundreds of millions of dollars. The FDA requires these studies to randomly allocate men into two comparison groups. One group receives the new medicine being tested. The other group gets an ineffective fake, called a placebo. Assuming the study is performed in an acceptable manner, the FDA will approve a new drug for commercial use, only if the men who are receiving the new medicine outlive those treated with the placebo by a specified margin without excessive toxicity.