FDA approves Xtandi for non-metastatic castration-sensitive prostate cancer with biochemical recurrence

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FDA approved Xtandi (enzalutamide) for non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

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The Pazdurs in their garden with their dog, Cleo. The dog’s full name is Cleopatra, Queen of Denial.In 1999, Rick Pazdur went in for a “perfunctory” final interview at FDA. Thinking it would only take a few minutes, his wife, Mary, decided to wait and have a quick cup of coffee at a nearby restaurant—Hooters.
Pfizer Inc. and Astellas Pharma Inc. announced positive topline results from the overall survival analysis from the phase III EMBARK study evaluating Xtandi (enzalutamide), an androgen receptor signaling inhibitor, in combination with leuprolide, and as a monotherapy in men with non-metastatic hormone-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

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