The long awaited FDA approval of Zytiga (abiraterone acetate), a once-daily oral agent, for the treatment of castration-resistant, metastatic prostate cancer following docetaxel chemotherapy has happened! Malecare celebrates this approval as it celebrates the significant numbers of new drug approvals we have had over the last year and one half. The approval of Zytiga represents a major clinical breakthrough for men who previously had no good clinical therapies available to them.
Zytiga is a new class of medication that suppresses androgen (testosterone) synthesis in a new way. Zytiga targets the enzyme, Cyp17 lyase, which is involved in the complex conversion of cholesterol to testosterone. Zytiga has demonstrated the ability to reduce intratumoral testosterone levels far below the levels achieved with current androgen suppressive medications. This new pathway resulted in a profound survival advantage for men in a large, randomized Phase III clinical trial.
Clinicians now have an additional, powerful, and relatively safe, life-prolonging treatment for men with advanced prostate cancer who have failed chemotherapy with taxotere. Zytiga offers clinicians and advanced prostate cancer survivors another bite at the apple.
The next step is to evaluate Zytiga as a possible treatment for men with castrate resistant prostate cancer with minimal symptoms prior to chemotherapy. A second, large, already fully accrued Phase III clinical trial is underway to make this assessment.
The original trials for this breakout drug have been supported and accelerated by the Department of Defense Prostate Cancer Research Program (DoD PCRP) through the Clinical Trials Consortium, the program that I have been urging you to support by contacting your members of congress.
Besides evaluating the efficacy of Zytiga for less progressed prostate cancer there will need to be work done evaluating the sequencing of this drug into the milieu of other treatments like Taxotere and Provenge.
The approval of Zytiga is a great day for prostate cancer patients seeking life-prolonging therapy for advanced disease. The believe that the future will be even brighter.
Read the announcement from the FDA
Joel T. Nowak, M.A., M.S.W.