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Enhertu granted Priority Review for HER2-low mBC
Enhertu granted Priority Review for HER2-low mBC.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n 25 July 2022 07:00 BST\n \n \n \n \n \n \n Enhertu\n \n \n granted Priority Review in the US for\n \n \n \n \n patients with HER2-low metastatic breast cancer\n \n \n \n \n \n \n \n \n \n Based on DESTINY-Breast04 results which showed AstraZeneca and Daiichi Sankyo's Enhertu is the first HER2-directed therapy to demonstrate a survival benefit in this population\n \n \n \n \n \n \n \n \n \n Application being evaluated under FDA Real-Time Oncology Review and Project Orbis\n \n \n \n \n \n \n AstraZeneca and Daiichi Sankyo have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the US with unresectable or metastatic HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridisation [ISH]-negative) breast cancer who have received a prior therapy in the metastatic setting.\n The application has been granted Priority Review.\n \n \n \n \n \n \n Enhertu\n \n is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.\n \n \n \n \n \n The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements 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 fourth quarter of 2022.\n \n \n \n \n \n The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) programme and Project Orbis, two initiatives of the FDA which are designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners.\n \n \n \n \n \n Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said:\n \"The data from DESTINY-Breast04 represent the first time a HER2-targeted therapy has shown a survival benefit in patients with HER2-low metastatic breast cance...