medwireNews: The EMA has recommended approval of relugolix for the treatment of advanced hormone-sensitive prostate cancer.
The positive opinion follows US FDA approval of relugolix in December 2020. Both decisions are based on findings from the phase 3 HERO trial in which the gonadotropin-releasing hormone antagonist achieved a medical castration rate of 96.7% in this patient population, which was superior to the rate of 88.8% with leuprolide acetate.
Relugolix will be available as 120 mg tablets.
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