Jevtana has been approved by the Food and Drug Administration (FDA) for use in combination with the steroid prednisone, only after treatment with docetaxel (also with prednisone) has already been completed. Docetaxel is a widely used chemotherapy drug that was approved by the FDA several years ago.
Jevtana received FDA approval in large part due to the positive results that came out of a Phase III clinical study comparing Jevtana with mitoxantrone. The study showed that Jevtana resulted in a roughly 3 month increased survival in men with advanced prostate cancer that was resistant to hormone therapy when compared to mitoxantrone.
Jevtana represents an important step forward for men who are facing prostate cancer which has become resistant to hormone therapy and has also ceased responding to docetaxel. Jevtana's ability to increase survival in men who have few other options offers them a dose of hope.
One point of controversy that has arisen since FDA approval of Jevtana and other drugs designed to treat advanced prostate cancer is the high cost of these treatments. Jevtana and similar drugs cost tens of thousands of dollars over the course of a few months.
de Bono JB. Oudard S, Ozguroglu M, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. The Lancet, Volume 376, Issue 9747, Pages 1147 - 1154, 2 October 2010