In the middle of November, the Food and Drug Administration (FDA) approved Enzalutamide (Xtandi) for high risk prostate cancer patients with a rise in PSA levels following radical prostatectomy and/or radiotherapy.

Xtandi (taken daily orally) works by preventing the connection of testosterone (a male sex hormone) to the cancer cells, thereby inhibiting their ability to grow and divide.

The approval was based on results from a clinical trial enrolling 1,068 patients meeting the abovementioned criteria. Patients were randomly assigned to receive either Xtandi plus standard hormonal therapy (study group 1), Xtandi only (study group 2), or placebo plus standard hormonal therapy (control group).

At the end of the follow-up period, the study results pointed towards a significantly lower risk of disease progression among the two study groups receiving Xtandi (with or without standard hormonal therapy), compared to the control group receiving placebo with standard hormonal therapy.

The most common side effects observed among patients receiving Xtandi included hot flushes, fatigue, musculoskeletal pain and hemorrhage.

Based on the promising results, the researchers believe that Xtandi may reduce the risk of prostate cancer progression among high risk patients with a rise in PSA levels, following radical prostatectomy and/or radiotherapy.