Lynparza in combination with abiraterone granted priority review in the US for patients with metastatic castration-resistant prostate cancer

AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone (Zytiga) and prednisone or prednisolone has been accepted and granted Priority Review in the US for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).Lynparza is being jointly developed and commercialised by AstraZeneca and MSD.

The FDA grants Priority Review to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2022.

The sNDA was based on results from the PROpel Phase III trial presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium and later published in NEJM Evidence (previously cited).

These results showed Lynparza in combination with abiraterone 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 for abiraterone alone. the safety and tolerability of lynparza in combination with abiraterone was in line with that observed in prior clinical trials and the known profiles of the individual medicines.