Enhertu approved in China for HER2‑low or HER2‑ultralow metastatic breast cancer | iPharmaCenter

Enhertu (trastuzumab deruxtecan) has received marketing authorization in China as the first HER2‑targeting therapy for people with HER2‑low or HER2‑ultralow metastatic breast cancer whose disease has worsened after at least one endocrine treatment in the metastatic setting. The decision is supported by phase 3 DESTINY‑Breast06 data showing clinically meaningful improvements in progression‑free survival versus standard chemotherapy.

New indication in China

The National Medical Products Administration (NMPA) has cleared Enhertu for adults with unresectable or metastatic, hormone receptor (HR)–positive breast cancer with HER2‑low (IHC 1+ or IHC 2+/ISH‑) or HER2‑ultralow status (IHC 0 with membrane staining) after progression on one or more endocrine therapies in the metastatic setting.

Enhertu is an engineered HER2‑directed antibody–drug conjugate (ADC) with a DXd payload, discovered by Daiichi Sankyo and co‑developed and co‑commercialized with AstraZeneca.

Breast cancer burden and biology in China

Breast cancer is the second most frequently diagnosed malignancy among women in China, with an estimated 357,000 new cases and about 75,000 deaths reported in 2022.

HR‑positive, HER2‑negative disease represents around 70% of breast cancers in China, and many tumors in this group still express low levels of HER2 despite being labeled HER2‑negative, creating an opportunity for HER2‑targeted ADCs such as Enhertu.

DESTINY‑Breast06 efficacy results

In chemotherapy‑naïve patients with HR‑positive, HER2‑low metastatic breast cancer, Enhertu reduced the risk of disease progression or death by 38% compared with physician’s‑choice chemotherapy, as assessed by blinded independent central review.

Median progression‑free survival was 13.2 months with Enhertu versus 8.1 months with chemotherapy in the HER2‑low cohort, while the confirmed objective response rate was 56.5% versus 32.2%, and median duration of response was 14.1 months versus 8.6 months, respectively.

Outcomes in HER2‑ultralow disease

Among patients with HER2‑ultralow metastatic breast cancer, median progression‑free survival reached 13.2 months with Enhertu compared with 8.3 months for chemotherapy.

In this HER2‑ultralow subgroup, the confirmed objective response rate was 61.8% with Enhertu versus 26.3% with chemotherapy, with median duration of response of 14.3 months and 14.1 months, respectively.

Positioning of Enhertu in China

This latest decision moves Enhertu into earlier‑line treatment for HR‑positive, HER2‑low metastatic breast cancer while expanding eligibility to include patients with HER2‑ultralow tumors.

The breast cancer approval is the fifth indication for Enhertu in China across three different tumor types in under three years, underscoring the growing role of this ADC in Chinese oncology practice