Enhertu granted Priority Review in the US for patients with HER2-low metastatic breast cancer
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. Application being evaluated under FDA Real-Time Oncology Review and Project Orbis.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