Second approved indication for enzalutamide later this year?


Astellas Pharma and Medivation have submitted all relevant data to the US Food & Drug Administration (FDA) in support of their application for approval of enzalutamide (Xtandi) for the treatment of men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (CRPC).

A detailed media release from the two companies is available on line. This application is based on data from the PREVAIL trial. The full results of this trial were presented earlier this year at the Genitourinary Cancer Symposium, although the core findings of the study were initially announced in October 2013.

It seems likely to The “New” Prostate Cancer InfoLink that the FDA will approve this application within a relatively short time frame, and that approval of enzalutamide in this indication can be expected in the second half of 2014.

5 Responses

  1. I have had prostate cancer for 7 years and am now going to have to change from straightforward ADT drugs (Zoladex and Casodex) as PSA shooting up.

    I know there has been the PREVAIL trial on enzalutamide. Is there any evidence whether this is best option rather than abiraterone, which I think is main alternative?

  2. Dear Robin:

    There are, as yet, no head to head trial data that allow us to make any specific recommendations about whether it is “better” for any specific patient to get treatment with enzalutamide before abiraterone acetate or vice versa. A second issue that is important here is whether you have previously been treated with chemotherapy and, therefore, if you haven’t, whether you can actually receive treatment yet with enzalutamide, since it hasn’t been formally approved yet for the treatment of chemotherapy-naive, castration-resistant prostate cancer in either the UK or the USA (or anywhere else that I am aware of). That’s an issue you will need to discuss with your doctors.

    Having said that, there do appear to be some theoretical patient conveniences to treatment with enzalutamide: it doesn’t have to be taken with prednisone, and it doesn’t have to be taken with food.

    It seems likely to me that, over time, we shall discover that there are some types of patient who do better on enzalutamide first and others who do better on abiraterone acetate first, but I don’t expect to see any good data that will tease out information like this for quite a while yet, so all I can really tell you is that, if you think you have a preference, discuss it with your doctor and see if he is OK with that.

  3. .
    Thanks, Have not had chemotherapy so maybe abiraterone is only option, as yet. Will post what recommendation I get. My treatment is at the Marsden in London, UK.

  4. Robin:

    If anyone in the UK can get you enzalutamide to treat chemotherapy-naive CRPC, it is likely to be at the Royal Marsden!

  5. We shall see

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