Daiichi Sankyo and AstraZeneca have received approval from China’s National Medical Products Administration (NMPA) for Datroway (datopotamab deruxtecan) to treat adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative breast cancer.
This approval applies to patients who have previously undergone endocrine therapy and at least one line of chemotherapy in an advanced setting. The drug is a TROP2-directed antibody drug conjugate (ADC).
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By GlobalDataAstraZeneca oncology haematology business unit executive vice-president Dave Fredrickson said: “We are proud to bring Datroway to patients in China for the first time, offering those with metastatic HR positive, HER2 negative breast cancer a new and needed option.”
The approval of Datroway is based on findings from the TROPION-Breast01 Phase III trial, which demonstrated a 37% decline in disease progression or death risk compared to the investigator’s choice of chemotherapy.
In an analysis of 83 subjects from China enrolled in the trial, the median progression free survival (PFS) for Datroway was 8.1 months, while chemotherapy yielded a median PFS of 4.2 months.
The randomised, global, multicentre, open-label TROPION-Breast01 study is designed to evaluate the safety and efficacy of Datroway administered intravenously once every 21 days against the investigator’s choice of single-agent chemotherapy in patients who have progressed on prior treatments.
The trial included 732 participants from various regions, including Asia, Africa, Europe, South America and North America.
Datroway is part of a clinical development programme that encompasses over 20 trials assessing its efficacy and safety across multiple cancer types.
It is currently approved in more than 35 countries to treat advanced HR positive, HER2 negative breast cancer.
Daiichi Sankyo and AstraZeneca have collaborated on the development and commercialisation of Datroway since July 2020, with Daiichi Sankyo retaining exclusive rights in Japan.
Daiichi Sankyo will manufacture and supply Datroway and its other ADC, Enhertu.
In June 2025, the US Food and Drug Administration (FDA) approved Datroway for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
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