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FDA Approvals, News & UpdatesNewsworthyProstate Cancer

Erleada First Drug Approved for Patients with Nonmetastatic Prostate Cancer

On February 14, 2018, the FDA approved Erleada (apalutamide; from Janssen) for the treatment of patients with nonmetastatic, castration-resistant prostate cancer.
May 2018 Cancer Biomarkers and Molecular Testing

On February 14, 2018, the FDA approved Erleada (apalutamide; from Janssen) for the treatment of patients with nonmetastatic, castration-resistant prostate cancer (prostate cancer that has not spread). Erleada is the first treatment approved by the FDA for patients with nonmetastatic castrationresistant 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.

In the clinical trial that led to this approval, the average length of survival without the cancer spreading to other parts of the body (metastasis-free survival) was 40.5 months with Erleada versus 16.2 months with placebo.The common side effects with Erleada include fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, falls, hot flushes, decreased appetite, fractures, and peripheral edema.

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Last modified: July 17, 2018

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