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FDA Approves Apalutamide for Nonmetastatic Castration-Resistant Prostate Cancer

Jason M. Broderick @jasoncology
Published: Wednesday, Feb 14, 2018

Richard Pazdur, MD
Richard Pazdur, MD
The FDA has approved apalutamide (Erleada) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC). The drug is now the first FDA-approved treatment in this setting.

“There is a population of men with prostate cancer who have no visible evidence of spread but who have a rise in their blood markers. These patients can have a poor prognosis, and until now, the optimal management of their cancer remained an enigma. These findings suggest there may finally be a treatment that holds real promise for extending their health and their lives,” ASCO expert Sumanta K. Pal, MD, a medical oncologist and assistant clinical professor in the Department of Medical Oncology and Therapeutics Research at City of Hope, said in a statement when the SPARTAN data were presented at the 2018 Genitourinary Cancers Symposium.
Small EJ, Saad F, Chowdhury S et al. SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) versus placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC). J Clin Oncol 36, 2018 (suppl 6s; abstract 161).

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