For the first time, the FDA has approved a medication for the treatment of non-metastatic castration-resistant prostate cancer (CRPC), according to a press release from the agency. The drug, apalutamide, is an orally administered androgen receptor inhibitor.

According to the FDA, the approval is the first to use the end point of metastasis-free survival (MFS). The agency based its approval on safety and efficacy data from the phase III randomized, double-blind clinical trial (SPARTAN) that included 1207 patients with non-metastatic CRPC. In that trial, the median MFS was 40.5 months for men taking apalutamide compared with 16.2 months for those receiving a placebo. Apalutamide-treated patients had a significant 72% decreased risk of metastasis or death compared with placebo recipients.

Details of the SPARTAN trial, which were published online in the New England Journal of Medicine, were presented in a press conference preceding the 2018 Genitourinary Cancers Symposium in San Francisco by lead investigator Eric Jay Small, MD, of the University of California San Francisco Helen Diller Family Comprehensive Cancer Center.

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“Treatment with apalutamide was generally well tolerated, with no impact on quality of life scores and with low rates of discontinuation due to treatment-related adverse events,” Dr Small said. “Overall, these data suggest that apalutamide should now be considered a new standard of care for men with high-risk non-metastatic castration-resistant prostate cancer.”

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The drug will be marketed as Erleada by its developer, Janssen Pharmaceutical Companies.


FDA Press Release.  FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint.

Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018. doi: 10.1056/NEJMoa1715546