medwireNews: The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending wider use of the steroidal CYP17A1 inhibitor abiraterone acetate.
The change in marketing authorisation will allow abiraterone acetate plus prednisone or prednisolone to be used for the treatment of newly diagnosed men with high-risk metastatic hormone-sensitive prostate cancer alongside androgen-deprivation therapy (ADT).
This follows earlier approval for the use of the agent in men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after ADT failure but who are not yet candidates for chemotherapy. Abiraterone acetate may also be used for men who have progressed on or following docetaxel-based chemotherapy.
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