AstraZeneca Lynparza+biraterone recommended for E.U. approval in mCRPC

The company states: "AstraZeneca (AZN) and MSD’s (MRK) Lynparza in combination with abiraterone and prednisone or prednisolone has been recommended for marketing authorisation in the European Union for the treatment of adult patients with metastatic castration-resistant prostate cancer, mCRPC, for whom chemotherapy is not clinically indicated. The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on results from the PROpel Phase III trial which were published in NEJM Evidence in June 2022. In the trial, Lynparza in combination with abiraterone and prednisone or prednisolone, reduced the risk of disease progression or death by 34% versus abiraterone alone. Median radiographic progression-free survival was 24.8 months for Lynparza plus abiraterone versus 16.6 months for abiraterone alone. Results also showed that Lynparza in combination with abiraterone extended median rPFS by almost one year, with a median rPFS of 27.6 months versus 16.4 with abiraterone alone, as assessed by blinded independent central review. Updated results also showed a favourable trend in improved overall survival with Lynparza plus abiraterone versus abiraterone alone, however the difference did not reach statistical significance at the time of this data cut-off."Reference Link