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FDA Approves Apalutamide, First Treatment for Nonmetastatic Castration-Resistant Prostate Cancer


FDA has approved apalutamide, the first treatment for nonmetastatic castration-resistant prostate cancer, based on results from a phase 3 study that showed the drug reduced the risk of metastasis or death by 72% and improved median metastasis-free survival by more than 2 years.

Apalutamide, which has been shown to improve median metastasis-free survival by more than 2 years, has been approved by the FDA to treat patients with nonmetastatic castration-resistant prostate cancer (CRPC). Prostate cancer is the second most common form of cancer in US men and approximately 10% to 20% of these cases are castration resistant, according to the National Cancer Institute at the National Institutes of Health.

The drug, which will be sold as Erleada by the Janssen Pharmaceutical Companies of Johnson & Johnson, is an investigational, next-generation androgen receptor inhibitor. The drug blocks the effect of androgens, a hormone that can promote tumor growth. It is the first FDA-approved treatment for this indication. The approval was based on the phase 3 SPARTAN trial, which also found that apalutamide reduced the risk of metastasis or death by 72%.

“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,” 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, said in a statement. “In the trial supporting approval, Erleada 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."

The results of the SPARTAN trial were presented at the American Society of Clinical Oncology 2018 Genitourinary Cancers Symposium in San Francisco, California, and simultaneously published in The New England Journal of Medicine.1

The randomized, double-blind, placebo-controlled, multicenter study enrolled 1207 patients, who were randomized 2:1 to receive apalutamide in combination with androgen deprivation therapy (ADT) or placebo.

“While there have been advances in the treatment of prostate cancer over the years, metastatic castration-resistant prostate cancer is still a lethal disease. These compelling results are the first to show that metastases can be delayed in these patients,” Eric Small, M.D. FASCO, Professor of Medicine, and Chief of the Division of Hematology and Oncology at the University of California, San Francisco, and lead SPARTAN study investigator, said in a statement. “These data suggest that apalutamide could potentially be a new standard of care for patients with nonmetastatic castration-resistant prostate cancer.”


1. Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Eng J Med. Published online February 8, 2017. Accessed on February 14, 2018. doi: 10.1056/NEJMoa1715546

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