Medivation/Astellas seek expanded indication for enzalutamide in Europe

According to a media release this morning from Medivation and Astellas Pharma, the companies have completed submission of data in support of the expansion of the European Marketing Authorization for enzalutamide — to include men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC).

This submission, like the prior submission in the USA, is based on data from patients enrolled in the PREVAIL trial. The full results of the PREVAIL trial were presented earlier this year at the Genitourinary Cancers symposium in San Francisco.

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