Apalutamide (Erleada) approved in EU for treatment of nmCRPC

Yesterday, Janssen Pharmaceuticals announced the approval of apalutamide (Erleada) by the European Commission (EC) for the treatment of men with non-metastatic, castration-resistant prostate cancer (nmCRPC) who are at high risk for development of metastatic disease.

The approval is based on data from the SPARTAN trial. Apalutamide was approved for this indication in the US nearly a year ago (see here).

The full text of the media release issued by Janssen Pharmaceuticals can be reviewed on line. However, the speed with which it may be possible for appropriate patients to get treatment with apalutamide will inevitably vary from country to country across the European Union (EU).

We should note that Astellas Pharma received EC approval of enzalutamide (Xtandi) in Europe for what appears to be an identical indication in October 2018 (see here).

2 Responses

  1. Taken as a whole, these developments reflect a paradigm shift in our understanding of prostate cancer as a systemic disease that requires long-term management vs a localized disease of the prostate gland which can be cured by surgery or radiation.

    The challenge now is to fulfill the objectives and goals of precision medicine and personalized oncology by learning how to sequence treatments for a particular patient that reflect not only the unique characteristics of his disease but also his quality of life concerns and willingness to take risks by trying promising treatments that have not yet been empirically validated.

  2. Dear pfadtag:

    I am not at all sure that I agree with the idea that these developments are the “paradigm shift” you describe. It has long been understood (50 or so years) that there were at least three different, general types of prostate cancer: low-risk forms of prostate cancer that were curable; not so low-risk forms of prostate cancer that might be curable but which might also progress and metastasize; and high-risk forms of prostate cancer that were either already metastatic by the time they were diagnosed or that came with a high probability for metastasis.

    The development of agents that can be used to treat high-risk forms of prostate cancer after they are clearly no longer manageable with local forms of therapy is — in all honesty — just one more step on the path toward trying to find a way to stop these forms of prostate cancer progressing at all either before or after they are no longer amenable to localized therapy. Not one of the available agents currently approved to treat any form of progressive, non-localized of prostate cancer can currently be administered with curative intent. This has been the case since Huggins and his colleagues first started to apply androgen deprivation therapy back in the 1940s. We are making continued progress, but I don’t see a paradigm shift here.

    By contrast, there has been a massive paradigm shift in the management of low- and very low-risk forms of prostate cancer with the acceptance of the idea that we can simply monitor most of these men (on active surveillance) instead of treating them until there are clear signals of an increase in their risk level.

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