medwireNews: The EMA’s Committee for Medicinal Products for Human Use has recommended granting a marketing authorization to darolutamide for nonmetastatic castration-resistant prostate cancer (CRPC).
The androgen receptor inhibitor, which will be available as 300 mg tablets, is indicated for men who are at high risk for developing metastases.
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Darolutamide is the third antiandrogen, after enzalutamide and apalutamide, to receive a positive opinion from the EMA for this indication. All three agents are also approved in the USA for this patient population.
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