AstraZeneca's (AZN) ENHERTU Granted Priority Review in the US for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen

ENHERTU® Granted Priority Review in the U.S. for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen

Based on groundbreaking DESTINY-Breast03 results showing Daiichi Sankyo and AstraZenecas ENHERTU reduced the risk of disease progression or death by 72% versus ado-trastuzumab emtansine (T-DM1) Application being evaluated under FDA Real-Time Oncology Review and Project Orbis

TOKYO & MUNICH & BASKING RIDGE, N.J.--(BUSINESS WIRE)-- Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca (LSE/STO/Nasdaq: AZN) have received notification of acceptance by the U.S. Food and Drug Administration (FDA) of the supplemental Biologics License Application (sBLA) of ENHERTU® (fam-trastuzumab deruxtecan-nxki) for the... More