FDA Approves Erleada for Nonmetastatic Castration-Resistant Prostate Cancer

The Food and Drug Administration has approved Erleada for nonmetastatic castration-resistant prostate cancer treatment. This is the first FDA-approved drug for men with nonmetastatic prostate cancer being treated with androgen deprivation therapy (hormone therapy) who are experiencing a rise in PSA (prostate-specific antigen) levels but have no visible signs of disease spread.

Erleada (apalutamide, which was previously called ARN-509), is now an option for men whose prostate cancer is not visibly spreading and who are not responding to hormone therapy.

Until now, this population of men would typically continue receiving androgen-deprivation treatment even though the benefits were declining.

Approval of Erleada came about based on the results of a phase 3 clinical trial called SPARTAN, which pitted Erleada against placebo in 1,207 men who had nonmetastatic castration-resistant prostate cancer and rapidly rising PSA levels. A total of 806 men received apalutamide and 401 were in the placebo group.

The findings of the study were as follows:

  • Median metastasis-free survival in the apalutamide group was 40.5 months compared with 16.2 months in the placebo group, which represents a 72 percent reduction in risk of metastasis or death
  • Trial regimen was stopped because of progressive disease in 155 (19.3%) of men in the apalutamide group and in 201 (52.8%) in the placebo group
  • Time to progression of symptoms was significantly longer in the treatment group compared with placebo
  • Adverse effects occurred at a higher rate with apalutamide than with placebo, as follows: rash (23.8% vs 5.5%), hypothyroidism (8.1% vs. 2.0%), and fracture (11.7% vs. 6.5%), respectively

On the basis of these findings, the FDA approved Erleada for men with nonmetastatic castration-resistant prostate cancer. Men who are facing this prostate cancer challenge should discuss the possibility of this treatment approach with their healthcare team.

Read more in our Prostate Cancer Health Center.

References

Food and Drug Administration. FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint. 2018 Feb 14

Smith MR et al. Apalutamide treatment and metastasis-free survival in prostate cancer. New England Journal of Medicine 2018 Feb 8


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