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 BRCA-mutated (BRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. The product was jointly developed and commercialized by AstraZeneca and Merck.
About Priority Review
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. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2022.
Breast cancer is now the most diagnosed cancer worldwide with an estimated 2.3 million patients diagnosed in 2020. 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.
The sNDA was based on results from the OlympiA Phase III trial presented during the 20...
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