Zytiga Approved for Use Earlier in Patient Treatment

As I was saying, advances in treatment for patients continue to accelerate…

This just in from Bloomberg News: Johnson & Johnson has been granted approval by the U.S. Food and Drug Administration for Zytiga (abiraterone) to be used earlier in the patient treatment, prior to chemotherapy. The drug, taken in pill form, was originally approved in April 2011 for patients who had had grown resistant to hormone therapy AND failed chemo treatments. Zytiga is one of five new drugs that have come to market in the past two years for prostate cancer patients with advanced disease. This new approval, less than than two years since its original indication approval is encouraging news for patients.

Zytiga is just one encouraging example of how newly approved drugs are being tested earlier in the course of treatment and, in some studies, in combination to improve patient outcomes. What’s more, there are more than 28 other new prostate drugs targeted for prostate cancer in Phase III trials. Add this news to my last post about improvements in PET scan imaging that are enabling clinicians to see and treat metastatic lesions earlier than ever before, and you can understand my optimism. It’s why I constantly remind patients that there is no better time than today to be a prostate cancer patient–if you have to be one.

Of course, from my perspective I am also pleased to add that PCF funded over $8 million for competitive research awards centered on Zytiga. The funding was used to help determine the mechanism of action of the agent, the execution of Phase II clinical trials, and continues to fund a determination of mechanisms of patient resistance to the agent. The PCF-DoD Clinical Trials Consortium, along with funded investigators at the Royal Marsden Hospital in London, were instrumental in designing the pivotal Phase III clinical trial that supported the FDA decision to approve the agent.

Another advance–perhaps even a life-giving holiday gift–for patients.

 

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19 Responses to “Zytiga Approved for Use Earlier in Patient Treatment”

  1. Great news, Dan! Thanks for keeping us posted!

  2. We need more positive reports like this.

  3. Dan, I have been involved in the Phase III clinical trial of this drug for almost three and a half years. In my case, it has worked very well. Side effects are very minimal. Am delighted by the number of drugs/treatments available now. When I started my journey (over nine years ago), there was only one option after hormone therapy.

    • John,

      Thank you for sharing your experience with the drug trial. It’s important that other patients hear feedback like yours. I am very pleased that the treatment worked so well for you.

      Wishing you abundant health,
      Dan

    • JOHN I AM NEW TO THE BLOG AND JUST CAME ACCROSS YOUR INFO RE ZYTIGA I AM 88 YEARS OF AGE . DIAGNOSE STAGE 4, LUPRON, CAODEX, TRIED ,PSA STILL RISING. RADIATION NOW FOR METATESES IN SPINE WAS JUST PUT ON ZYDIGA. VERY EXPENSIVE.INITIAL HELP VIA ZIDIGA PATIENT ASSISTANCE PROGRAM. . ARE YOU FAMILIAR WITH JOHNSON/JOHSON ASSSISTANCE PROGRAM? ANY INFO WILL HELP. NEW TO COMPUTER. I AM STILL A NOVICE

  4. Good news indeed. Hopefully, we will hear in not too many months that Xtandi (formerly enzalutimide / MDV3100) currently in trials will also receive approval for pre-chemo use.

    -Craig

  5. I was at my doctor’s office this morning and we were discussing next steps after the prostate cancer had spread farther in my spine. He was hopeful that Zytiga would be approved for earlier use.
    This afternoon my doctor called excited about the good news. Now he has an additional tool for me and others in his practice.

  6. This is excellent news. Now I just hope that the Netherlands’ government will follow the American lead.

  7. Anything that precedes and promises to preclude chemo is GREAT news!

  8. Hi, Great Birthday gift for me to receive this GOOD NEWS..thanks for doing what you do. Merry Christmas to you and yours

  9. My doctor called me the very next day to tell me to start taking Zytiga. It’s nice to know that my small town oncologist is on top of things.

  10. This is Great news,another weapon to fight this dis-ease. I recently after five years of no detection,have had a spike in my psa to 0.03 then six months later 0.04 so this Drug Zytiga could be started sooner then later .Great News! thank you Dan for your honesty in shareing My check is in the Mail! Tom Gunn

  11. My husband is to start zytiga after failing enzalutamide.Because he has Medicare and and Part D prescription coverage it will cost much more than we can afford. If you have commercial coverage they will give you a coupon to get it for only $20 per mo. I have looked at 5 funding sites and no one gives assistance for this that I could find.
    Anyone have any ideas.?
    thanks

  12. Hi Dan
    My partner was diagnsed 2 yrs ago and now he has neck pain which progressed to feeling numb in his fingers/hands,legs.
    Could be this be metastasis to the spine?

    • Dear Mojaki,

      As I am not a medical professional, I can not hypothesize on the cause of his pain. He should see his doctor and discuss his symptoms.

      Best wishes,
      Dan

  13. Hi
    Thanks very much Dan, he has been admitted to hospital and they are going to do some test.