Daiichi Sankyo and AstraZeneca’s ENHERTU (trastuzumab deruxtecan) has been approved in China as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens.

ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

In China, breast cancer is the most common cancer in women, with more than 415,000 cases diagnosed in 2020. 1 There were nearly 120,000 breast cancer deaths in China in 2020, representing approximately 18% of global breast cancer deaths.1 Approximately one in five cases of breast cancer are considered HER2 positive.

The approval by China’s National Medical Products Administration (NMPA) is based on the results of the DESTINY-Breast03 phase 3 trial, where ENHERTU demonstrated a 72% reduction in the risk of disease progression or death compared to trastuzumab emtansine (T-DM1) (hazard ratio [HR] = 0.28; 95% confidence interval [CI]: 0.22-0.37; p<0.000001) in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. The median progression- free survival (PFS) for patients treated with ENHERTU was not reached (95% CI: 18.5-NE) compared to 6.8 months for T-DM1 (95% CI: 5.6-8.2) as assessed by blinded independent central review (BICR). ENHERTU was granted Breakthrough Therapy Designation and priority review in 2022 by the China NMPA for this tumor type based on these data.

“This approval marks an important day for the breast cancer community in China as patients with HER2 positive metastatic breast cancer continue to need additional treatment options,” said Binghe Xu, MD, Professor and Director of the Department of Medical Oncology, Cancer Hospital and Institute Cancer Hospital, Chinese Academy of Medical Sciences. “Despite initial treatment, patients with HER2 positive metastatic breast cancer will often experience disease progression, demonstrating the importance of early systemic disease control and the potential for ENHERTU to help eligible patients with metastatic breast cancer.”