FDA approves use of enzalutamide in chemotherapy-naive mCRPC


This afternoon the U.S. Food & Drug Administration approved enzalutamide (Xtandi) as a treatment for patients with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) based on the results of the PREVAIL trial. Here is a link to a media release issued by Medivation and Astellas.

This means that, at least in theory, patients who have progressive metastatic disease on standard forms of treatment with androgen deprivation therapy (ADT) can now be treated, here in the USA, with either abiraterone acetate + prednisone or with enzalutamide alone, prior to any need for docetaxel-based chemotherapy. This is a particularly important opportunity for patients who, for whatever reason, are not good candidates for treatment with a corticosteroid like prednisone or prednisolone.

Although one can interpret data from the pivotal trials of enzalutamide and abiraterone acetate in chemotherapy-naive patients to suggest that enzalutamide may be associated with a more robust survival benefit, The “New” Prostate Cancer InfoLink would emphasize that this interpretation needs to be supported by strong “head to head” data before most experts would be willing to state that one form of therapy was truly “better” than the other for most patients.

3 Responses

  1. Great!!

  2. Does this mean I don’t have to pay a $2500/month copay now?

  3. No Hollis. Sorry. It doesn’t.

    FDA approval is only about whether a drug has actually been demonstrated to have specific effects in specific categories of patient. How your insurance provider addresses the cost issue is a whole other question that has nothing to do with the FDA.

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