LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone Receives Positive Opinion From EU CHMP as Treatment for Certain Patients With Metastatic Castration-Resistant Prostate Cancer
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of LYNPARZA in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated
RAHWAY, N.J.--(BUSINESS WIRE)--Nov 14, 2022--
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of LYNPARZA in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
The CHMP based its positive opinion on results from the Phase 3 PROpel trial presented at the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium and later published in NEJM Evidence.
These results showed LYNPARZA in combination with abiraterone and prednisone or prednisolone reduced the risk of disease progression or death by 34% (HR=0.66 [95% CI, 0.54-0.81]; p<0.0001) versus placebo plus abiraterone and prednisone or prednisolone. Median radiographic progression-free survival (rPFS) was 24.8 months for the LYNPARZA plus abiraterone arm versus 16.6 months for the placebo plus abiraterone arm, with or without homologous recombination repair (HRR) gene mutations.
