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Johnson & Johnson wins US FDA approval for prostate cancer drug

The U.S. Food and Drug Administration approved Johnson & Johnson drug Erleada, or apalutamide, to treat men with an early form of prostate cancer.

Erleada is the first FDA-approved drug to treat prostate cancer patients whose cancer has not spread but continues to grow despite hormone therapy. The cancer is known as nonmetastatic, castration-resistant prostate cancer.

The safety and efficacy of the drug was based on data from a phase 3 trial, called Spartan. The study included more than 1,200 men and showed that Erleada reduced the risk of disease spreading or death by 72% versus placebo.

According to the National Cancer Institute, about 161,360 men were diagnosed with prostate cancer in 2017, and 26,730 were expected to die of the disease.

The approval was granted to Johnson & Johnson unit Janssen Pharmaceutical Cos.