The US Food and Drug Administration (FDA) approved apalutamide as the first anti-cancer agent for the treatment of patients with non-metastatic castration-resistant prostate cancer, according to a press release.1

Apalutamide is also the first agent to be approved for meeting the primary endpoint of metastasis-free survival, a novel clinical outcome that measures the time it takes for a cancer to metastasize or for death to occur.

The FDA granted approval based on findings from the phase 3 SPARTAN study (ClinicalTrials.gov Identifier: NCT01946204), for which investigators randomly assigned 1207 men with non-metastatic castration-resistant prostate cancer receiving androgen-deprivation therapy and with rapidly increasing prostate-specific antigen levels to receive apalutamide 240 mg once daily or placebo.

Median metastasis-free survival was 40.5 months among patients treated with apalutamide vs 16.5 months for placebo (hazard ratio [HR] for metastasis or death, 0.28; 95% CI, 0.23-0.35; P < .001). Patients in the apalutamide arm also had a significantly longer time to symptomatic progression compared with placebo (HR, 0.045; 95% CI, 0.32-0.63; P < .001).2

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The most frequently observed adverse events for apalutamide included fatigue, hypertension, nausea, diarrhea, rash, weight loss, falls, arthralgia, decreased appetite, fractures, and peripheral edema.

References

  1. FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint [news release]. Silver Spring, MD: US Food and Drug Administration; Published February 14, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596768.htm. Accessed February 15, 2018.
  2. Smith MR, Saad F, Chowdhury, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018 Feb 8. doi: 10.1056/NEJMoa1715546 [Epub ahead of print]