FDA Approves Erleada (Apalutamide) for Some Prostate Cancers

The US Food and Drug Administration (FDA) has approved Erleada (apalutamide) to treat men with prostate cancer that has not yet spread (non-metastatic), but has a quickly rising PSA level while on treatment with hormone therapy, causing a big concern for cancer growth and spread. This is the first FDA-approved treatment for this high-risk type of prostate cancer, called non-metastatic castration-resistant prostate cancer.

Erleada works by blocking the effect of androgens, a type of hormone, on the tumor. Androgens such as testosterone can help tumors grow.

The FDA based its decision on a randomized clinical trial of 1,207 men with high-risk non-metastatic, castration-resistant prostate cancer. The trial measured the amount of time patients’ tumors did not spread (metastasize). All the men in the trial received hormone therapy, but only some also received Erleada. The men who received Erleada had no metastasis for an average 40.5 months compared to 16.2 months for the men who did not.

The FDA approved Erleada under its priority review program, which is designed to speed up approval of drugs that would significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition.

Common side effects of Erleada include fatigue, high blood pressure, rash, diarrhea, nausea, weight loss, joint pain, falls, hot flashes, decreased appetite, fractures and swelling in the limbs. More serious side effects include falls, fractures, and seizures.

Erleada is marketed by Janssen Pharmaceutical Companies.

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