Drug Approval | March 31, 2026
ENHERTU approved in China as first HER2-targeted ADC for early breast cancer
The decision is based on the phase 3 DESTINY-Breast11 trial
The decision is based on the phase 3 DESTINY-Breast11 trial
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy
This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
Second positive Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu in HER2-positive early breast cancer reinforces its potential to become a foundational treatment option in curative-intent setting
AstraZeneca and Daiichi Sankyo’s Enhertu followed by THP showed an improved safety profile vs. standard of care
DESTINY-Breast09 Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic patient population versus current 1st-line standard of care
Approval brings AstraZeneca and Daiichi Sankyo’s Enhertu earlier in the treatment of HR-positive, HER2-low breast cancer and broadens the eligible patient population to those with HER2-ultralow disease
Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
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