medwireNews: The EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the first-line use of add-on olaparib in men with metastatic castration-resistant prostate cancer (CRPC).
The CHMP states that the PARP inhibitor should be given alongside abiraterone and prednisone or prednisolone to adults in whom chemotherapy is not clinically indicated.
The decision is based on the phase 3 PROpel trial, which showed that adding olaparib to abiraterone plus prednisone significantly improved the primary endpoint of investigator-assessed radiographic progression-free survival as well as secondary endpoints such as time to first subsequent treatment.
Olaparib is already approved in Europe as a monotherapy for patients with metastatic CRPC and BRCA1/2 mutations who have progressed on prior therapy that included a new hormonal agent, as well as for other tumor types, such as ovarian and breast cancer.
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