Business
Lynparza granted FDA Priority Review for OlympiA
Lynparza granted FDA Priority Review for OlympiA.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 0051U\n AstraZeneca PLC\n 30 November 2021\n \n \n \n \n \n \n \n 30 November 2021 07:00 GMT\n \n \n \n \n \n \n Lynparza \n \n \n granted Priority Review in the US for \n \n \n \n BRCA-mutated HER2-negative high-risk early breast cancer\n \n \n \n \n \n First medicine targeting BRCA mutations to show clinical benefit in adjuvant setting \n \n \n \n \n \n AstraZeneca's supplemental New Drug Application (sNDA) for Lynparza (olaparib) has been accepted and granted Priority Review in the US for the adjuvant treatment of patients with\n BRCA-mutated (BRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. \n \n \n \n \n \n \n Lynparza \n \n is being jointly developed and commercialised by AstraZeneca and MSD.\n \n \n \n The Food and Drug Administration (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.\n \n 1\n \n The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2022.\n \n \n \n \n \n Breast cancer is now the most diagnosed cancer worldwide with an estimated 2.3 million patients diagnosed in 2020.2 Nearly 91% of all breast cancer patients are diagnosed at an early stage of disease and BRCA mutations are found in approximately 5% of patients.3,4,5\n \n \n \n \n \n The sNDA was based on results from the OlympiA Phase III trial \n \n presented\n \n during the 2021 American Society of Clinical Oncology Annual Meeting and simultaneously published in \n \n The New England Journal of Medicine\n \n .\n \n \n \n \n \n \n These results showed Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrence, second cancers or death by 42% versus placebo (based on a hazard ratio of 0.58; 99.5% confidence interval 0.41-0.82; p<0.0001). The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials.\n \n \n \n \n \n Lynparza \n is approved in \n \n the US...