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New indication alert: AZ and Daiichi’s Enhertu® (trastuzumab deruxtan) approved to treat unresectable or metastatic HER2-low breast cancer

Jul 12, 2023

AstraZeneca and Daiichi Sankyo announced that Enhertu®, their engineered HER2-directed antibody drug conjugate (ADC), has been approved in China as a monotherapy to treat patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.  The approval by China’s National Medical Products Administration is based on the results of the DESTINY-Breast04 Phase III trial 

Based on the same clinical trial, Enhertu® was approved in Japan for the above indication on 27 March 2023.