Darolutamide receives positive EMA decision for nonmetastatic CRPC
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.
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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