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.
Obviously great news for for all in need. The drug company has been gearing up for the approval for months with ads in all of the urology journal.
Keep up the great work!
From the regulatory perspective – Will urologist be allowed to prescribe abiraterone acetate or it will be in the hands of oncologists?
A urologist should be allowed to prescribe it, but if you are at the approved stage you should be having your cancer managed by an oncologist, not a urologist. – Joel
[…] we’re in the process of jumping thru the hoops to get started on Zytiga – the tradename for abiraterone acetate. It is reported to have minimal side effects all the while doing great and wonderful things for the […]
Hi, I got high risk Prostate Cancer 6 years ago. I am now 67 years old (young). Received intensive Radiation and have been on Casodex medication. Unfortunately my PSA levels have been creeping up and it is now recommended that I undergo Zytiga treatment. So far it has not been approved yet in South Africa but I am prepared to opt for this treatment despite the high cost (USD 4550.00) per monthly session. Can you advise/convince me why I should go this route.
Looking forward to your earliest response.
You have not given us a lot of information about either your current situation or the drugs and treatments that you have used. For instance you mentioned that you have been taking Casodex, did you also take Lupron or one of the alternative drugs that are similar? What about Taxotere? We need a lot more information. I suggest that you join the advanced prostate cancer on-line support group. I will send you an invitation. – Joel
As a spouse — it breaks my heart that it is cost prohibitive for so many people.
Rozanne, the hospital where my dad received it had financial assistance…anyone needing this treatment should discuss costs with their medical team.
Dad has prostate cancer which has not spread throughout his skeletal system. He has been on hormone blockers, had radiation and chemo, none of which have managed to control the fairly rapid spread of the disease. This is largely due to the fact that he has renal failure and has been on dialysis for 7yrs now. Doctor says Zytiga is the only option now but medical aid will not approve it unless he goes on the highest plan which is not financially possible for us. So is this the end of the road?
Financial aid might be available to help you afford the Zytiga. Call (in the United States) 1-855-998-4421 for financial assistance in getting Zytiga. – Joel