Expansion of indication for enzalutamide recommended in Europe


Late last week the Committee for Medicinal Products for Human Use (CHMP) in Europe recommended expansion of the marketing authorization for enzalutamide within member states of the European Union.

Specifically the expansion of the approval of enzalutamide would be for “the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.” This is closely comparable to the expanded indication that was recently approved here in the USA.

The actual approval of this use for enzalutamide in Europe still needs to be given by the European Union. Such approval is almost always a formality, and can be expected within the next couple of months. However, the actual accessibility of the product in individual European countries (except for patients who pay for the product themselves) will still take time, and the individual approval for cost coverage by specific regulatory authorities (e.g., the National Institute for Health and Care Excellence or NICE in England, and similar organizations in Germany and other nations).

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