FDA Approves Apalutamide for Nonmetastatic Prostate Cancer

The US Food and Drug Administration (FDA) today approved apalutamide (Erleada, Janssen) for the treatment of patients with nonmetastatic prostate cancer who are at high risk for disease spread because treatment with hormone therapy is not effective and thus their disease is castration resistant.


This is the first FDA-approved treatment for nonmetastatic, castration-resistant prostate cancer. It is also the first time the FDA used metastasis-free survival (MFS) as the primary endpoint in its decision making.

"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," said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a press statement.

Apalutamide is an orally administered androgen-receptor inhibitor.

 The FDA based its new approval on safety and efficacy data from the phase 3 SPARTAN (Selective Prostate Androgen Receptor Targeting With ARN-509) trial. Investigators randomly assigned 806 men to receive treatment with apalutamide (240 mg per day) and 401 to receive placebo; all participants also received hormone therapy, either gonadotropin-releasing hormone analogue therapy or surgical castration.

All of the men had also undergone previous definitive treatment, either surgery or radiotherapy, for prostate cancer, but their PSA scores doubled within 10 months or less following treatment, despite hormone therapy.

Median MFS, which was the primary endpoint, was 40.5 months in the apalutamide group as compared with 16.2 months in the placebo group (< .001). That translated into a 72% reduction in the relative risk for metastasis or death with the new drug (hazard ratio, 0.28; 95% confidence interval [CI], 0.23 - 0.35).

In addition, the results with apalutamide were superior for all secondary endpoints compared to placebo, including time to metastasis, progression-free survival, and time to symptomatic progression; all were significantly longer with apalutamide (< .001 for all comparisons).

February 15, 2018


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