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Lynparza combo recommended in the EU for mCRPC
Lynparza combo recommended in the EU for mCRPC.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n 14 November 2022 07:00 GMT\n \n \n \n \n \n \n Lynparza\n \n \n in combination with abiraterone recommended for approval\n in the EU by CHMP as 1st-line treatment for patients\nwith metastatic castration-resistant prostate cancer\n \n \n \n \n \n \n \n \n \n First PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent in this setting\n \n \n \n \n \n \n \n \n AstraZeneca and MSD's Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been recommended for marketing authorisation in the European Union (EU) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) for whom chemotherapy is not clinically indicated.\n \n \n \n \n \n \n \n The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the\n \n \n PROpel Phase III trial\n \n \n which were published in\n \n \n NEJM Evidence\n \n \n in June 2022.\n \n \n \n \n \n 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 (based on a hazard ratio [HR] of 0.66; 95% confidence interval [CI] 0.54-0.81; p<0.0001). Median radiographic progression-free survival (rPFS) 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 (BICR).\n \n \n \n \n \n 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 (analysis at 40% data maturity).\n \n \n \n \n \n Prostate cancer is the most common cancer in men in Europe, with an estimated 473,000 patients diagnosed and 108,000 deaths in 2020.1-2 Overall survival for patients with mCRPC is approximately three years in clinical trial settings, and even shorter in real-world settings.3 Approximately half of patients with mCRPC may receive only one line of active treatment, with dim...