More good news about abiraterone acetate

According to a media release from a division of Johnson & Johnson earlier today, an independent data monitoring committee has recommended that patients in the placebo arm of a Phase III trial of abiraterone acetate be offered treatment with abiraterone following unblinding of study data.

This recommendation comes in relation to the Phase III trial of abiraterone acetate in 1,195 patients with castration-resistant prostate cancer who had previously progressed after treatment with Taxotere, and who were randomized to receive treatment with abiraterone acetate + prednisone or placebo + prednisone. According to the media release, “The committee’s recommendation to unblind the study was based on a pre-specified interim analysis, which demonstrated a statistically significant improvement in overall survival and an acceptable safety profile.” In other words, the recommendation implies that the patients treated with abiraterone had better survival than the patients treated with placebo.

We do not have any specific data to report at the present time. The initial trial results are scheduled for presentation at a medical meeting in Milan, Italy on October 8-12. However, this announcement does imply the possibility that Johnson & Johnson will be able to submit a New Drug Application for abiraterone acetate in treatment of patients with castration-resistant prostate cancer before the end of 2010, with the possibility for approval by mid-2011 or perhaps earlier (depending on the quality of the data).

Johnson & Johnson also announced that the company plans to initiate an early access, compassionate use program for abiraterone acetate later this year. Patients will need to meet pre-specified medical criteria.  It is highly likely that eligibility criteria will be very similar to those specified for the original clinical trial itself, in which case eligible patients would have to have a rising PSA after treatment with at least two types of hormone therapy and after treatment with a docetaxel-based chemotherapy regimen. Participating treatment centers will be listed on the Clinical web site when they are ready to enroll patients. The goal is to have this program in operation at sites in the US some time in October 2010 and at sites outside the US in following months.

8 Responses

  1. Are you kidding me? No comments? Has everyone taken this for granted? Even if you have, this is big news and life saving for many men and their families …

  2. I agree no comments yet. Granted we don’t know what the results are yet but if it is significant like they say and pile this treatment on top of Provenge maybe we now really have some late treatment options to add some survival time.

  3. As you may be aware, I am taking part in the phase III trial of this drug and it is working for me. I have not experienced any side effects that I am aware of.
    I am so very pleased that the placebo side of the trial has been discontinued and that patients that were receiving the placebo, will now be offered the real drug.

    Now let’s hope that the FDA doesn’t sit on its hands and pushes foreward to approve this drug for general use, as soon as possible.

  4. Dear John:

    I believe that you are actually participating in the second of the two Phase III trials — the one for CRPC patients who had never received chemotherapy. The patients who are on placebo in that trial need to stay on drug so that we can be sure that abiraterone actually works in this earlier stage of the disease too.

    As it says above, there is every reason to believe that the FDA will be looking to approve abiraterone as soon as possible for patient who had progression after receipt of chenotherapy. The ball in now in Johnson & Johnson’s court, not the FDA’s. The company must provide all the relevant data to the FDA in the form of a New Drug Application or NDA. Only when they receive this full set of data will the FDA be able to determine whether to approve abiraterone. As we saw with cabazitaxel, the FDA can move pretty fast when they receive a well-organized submission.

  5. The advent of abiraterone is literally a life changing event. I wish to make my request very very simple for you. How do I get on the list for “compassionate use”? I am as serious as CANCER, because I have Phase III prostate cancer.

  6. Dear Mr. McMurray:

    For regulatory and legal reasons, the compassionate use trial will be limited to patients with mCRPC who have progressive disease after treatment with docetaxel-based chemotherapy (please see this link). You may, however, be eligible for other, ongoing abiraterone acetate trials.

  7. Sitemaster you have been very kind. I certainly didn’t think anyone would answer. I must admit that I don’t know the terminology that describes the situation I am in. I started on Zoladex only; we added Casodex; we then switched to Lupon. Nothing is keeping my PSA down. My oncologist says it is metastatic in my cervical region. I have had no chemotherapy at this time. Is a trial appropriate for me if I can get in one?

  8. Dear Mr. McMurray: If you have a rising PSA after trying a series of different hormone therapies (which apparently you have), then I think you should talk seriously to your doctor about clinical trials that might be suitable for you.

    Have a look at this article on this site. There are trials of dasatinib and ipilimumab for which you might be eligible (just to give two examples). There may well be others.

    It might also help you to join the social network associated with this site, where you will be able to get additional input and support from other patients.

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