European regulators approve enzalutamide for treatment of mCRPC

Yesterday, the European Commission approved the use of enzalutamide (Xtandi) for the treatment of metastatic, castration-resistant prostate cancer (mCRPC) in men who have progressive disease after at least one cycle of docetaxel-based chemotherapy. This is an expected approval for enzalutamide and comes some 9 months after enzalutamide was approved for the same indication here in the United States. A detailed media release from Medivation and Astellas is available.

The actual availability of enzalutamide in the different European nations for those covered under national health systems of different types will undoubtedly take longer to negotiate as individual nations seek to establish acceptable pricing for enzalutamide in individual countries.

Of course what we are all waiting to see are the results of the PREVAIL trial, in which enzalutamide was used to treat men with mCRPC who were chemotherapy-naive that the time of their treatment. Supposedly these data are expected some time between October and December this year — perhaps with a full presentation of the trial results at the Genitourinary Cancer Symposium in San Francisco in February 2014.

2 Responses

  1. What results from Zytiga vs enzalutamide for men who have not received docetaxel chemo?

  2. Dear Sidney:

    To date there has been no completed head-to-head trial of abiraterone acetate vs. enzalutamide in men with mCRPC who either have or have not been treated with docetaxel-based chemotherapy, so we have no real comparative data.

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