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