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FDA Approves Apalutamide (Erleada); the first treatment for non-metastatic castration-resistant prostate cancer

February 14, 2018 – Today the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada, also previously called ARN-509) for the treatment of non-metastatic castration-resistant prostate cancer (non-metastatic CRPC).  This clinical setting is when men who are being treated with androgen deprivation therapy (ADT) see their PSA levels begin to rise, but no metastases are visible yet on scans.  There were previously no FDA-approved treatments for non-metastatic CRPC, and patients typically continued to receive ADT, despite its diminishing benefit.

This approval is based on results from the randomized phase 3 SPARTAN clinical trial, which was presented last week at the 2018 ASCO Genitourinary Cancers Symposium.

The SPARTAN trial, led by PCF-funded investigator Eric Small, MD (University of California, San Francisco), tested the addition of apalutamide vs. placebo in 1,207 non-metastatic CRPC patients with rapidly rising PSA (PSA doubling time of 10 months or less), in addition to whatever treatment the men were already receiving (mostly ADT).  Patients selected for the trial had no distant metastases based on a bone scan and computed tomography (CT) of the pelvis, abdomen, chest, and head.  Some patients had malignant local or regional (pelvic) lymph nodes no larger than 2cm on the short axis.

Apalutamide was found to delay the time to metastatic disease by over 24 months on average (40.5 months in the apalutamide group versus 16.2 months in the placebo group).  This represents a 72% reduction in risk of metastasis or death.  The full results from the SPARTAN study have been published in the New England Journal of Medicine.

PCF funded the synthesis of apalutamide at UCLA by chemist Michael Jung, PhD, in collaboration with prostate cancer physician-scientist Charles Sawyers, MD (now at Memorial Sloan Kettering Cancer Center).

More information on this approval can be found here.

Andrea Miyahira
Dr. Andrea Miyahira has a PhD in cancer immunology, and is Director of Research at the Prostate Cancer Foundation.