EMA validates the MAA for Wevdury® (fuzuloparib) in combination with abiraterone acetate and prednisone/prednisolone for metastatic CRPC patients
European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for Wevdury® (fuzuloparib) in combination with abiraterone acetate and prednisone or prednisolone for the proposed indication of treating metastatic castration-resistant prostate cancer (mCRPC) in adult patients. This application is based on data from the SHR3162-III-305 study (FUZUPRO, NCT04691804), an international, multicenter, randomized, double-blind, placebo-controlled phase 3 trial.
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