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FDA Approves Apalutamide for Nonmetastatic, Castration-Resistant Prostate Cancer

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The U.S. Food and Drug Administration (FDA) today approved apalutamide (Erleada) for the treatment of patients with prostate cancer that has not spread, but that continues to grow despite treatment with hormone therapy. This is the first FDA-approved treatment for nonmetastatic, castration-resistant prostate cancer.

“This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “In the trial supporting approval, [apalutamide] had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public."

According to the National Cancer Institute (NCI) at the National Institutes of Health, prostate cancer is the second most common form of cancer in men in the United States. The NCI estimates approximately 161,360 men were diagnosed with prostate cancer in 2017, and 26,730 were expected to die of the disease. Approximately 10% to 20% of prostate cancer cases are castration-resistant, and up to 16% of these patients show no evidence that the cancer has spread at the time of the castration-resistant diagnosis.

Apalutamide works by blocking the effect of androgens on the tumor. These androgens, such as testosterone, can promote tumor growth. 

Safety and Efficacy in the SPARTAN Trial

The safety and efficacy of apalutamide was based on the SPARTAN randomized clinical trial of 1,207 patients with nonmetastatic, castration-resistant prostate cancer. Patients in the trial either received apalutamide or a placebo. All patients were also treated with hormone therapy, either with gonadotropin-releasing hormone analog therapy or with surgery to lower the amount of testosterone in their body (surgical castration). The median metastasis-free survival for patients taking apalutamide was 40.5 months compared to 16.2 months for patients taking a placebo.

Common side effects of apalutamide include fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, falls, hot flush, decreased appetite, fractures, and peripheral edema. Severe side effects of apalutamide include falls, fractures, and seizures.

This application was granted Priority Review, under which the FDA’s goal is to take action on an application within 6 months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.

The FDA granted the approval of apalutamide to Janssen Pharmaceutical Companies.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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