AstraZeneca, Daiichi Sankyo’s Enhertu approved for breast cancer in China

The National Medical Products Administration (NMPA) of China has granted approval to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for use as a monotherapy in adult patients with unresectable or metastatic HER2-low breast cancer.

The approval applies to patients who have undergone prior systemic therapy in a metastatic setting or experienced disease recurrence within six months of completing adjuvant chemotherapy.

Jointly developed and commercialised by AstraZeneca and Daiichi Sankyo, Enhertu is a specifically engineered HER2-directed antibody-drug conjugate (ADC). The approval from China’s NMPA is backed by the results of the DESTINY-Breast04 Phase III trial, and it follows a previous approval granted for Enhertu in patients with previously treated unresectable or metastatic HER2-positive breast cancer in February 2023.

Breast cancer is the most common cancer in Chinese women, with over 415,000 diagnoses and nearly 120,000 deaths recorded in 2020. It is estimated that half of all breast cancers are considered HER2-low.

Dave Fredrickson, Executive Vice President of the Oncology Business Unit at AstraZeneca, commented, “Patients with HR-positive or HR-negative, HER2-low metastatic breast cancer previously had few effective treatment options beyond chemotherapy. The results from the DESTINY-Breast04 trial show Enhertu provides a significant improvement in outcomes compared to chemotherapy for patients whose tumours are determined to be HER2-low via routine testing. This approval is an important advance in the way breast cancer is classified and treated in China and supports our vision to bring Enhertu to more patients worldwide.”

Kiminori Nagao, Head of the Asia, South & Central America Business Unit at Daiichi Sankyo, added, “This approval of Enhertu for patients with HER2-low metastatic breast cancer, which comes shortly after the approval of Enhertu in patients with HER2-positive disease, marks the first time patients with HER2-low tumours will have the opportunity to be treated with a HER2-directed therapy. Enhertu now has the potential to become a new standard of care treatment option in China for a broad range of patients with HER2-expressing metastatic breast cancer.”

In the DESTINY-Breast04 trial, Enhertu demonstrated a 50% reduction in the risk of disease progression or death versus standard chemotherapy in all randomised patients with HER2-low metastatic breast cancer, with a 36% reduction in the risk of death also observed when compared to chemotherapy. The safety profile was consistent with previous Enhertu trials, with no new safety signals identified.