On October 8, 2026 Daiichi Sankyo reported that Datroway (datopotamab deruxtecan) has been approved in China for the treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
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Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN).
The approval of Datroway by China’s National Medical Products Administration (NMPA) is based on results from the TROPION-Breast02 phase 3 trial, which were presented at the 2025 European Society for Medical Oncology Congress and subsequently published in Annals of Oncology.
In TROPION-Breast02, Datroway demonstrated a statistically significant 5.0 month improvement in median overall survival (OS) versus investigator’s choice of chemotherapy (hazard ratio [HR]=0.79; 95% confidence interval [CI]: 0.64-0.98; p=0.0291). Median OS was 23.7 months for patients treated with Datroway versus 18.7 months for those treated with chemotherapy. Datroway reduced the risk of disease progression or death by 43% compared to chemotherapy (HR=0.57; 95% CI: 0.47-0.69; p<0.0001) as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 10.8 months for patients treated with Datroway versus 5.6 months for those treated with chemotherapy in patients with metastatic TNBC who are not candidates for PD1/PD-L1 inhibitor therapy. Datroway also was associated with more robust treatment responses compared to chemotherapy, with an objective response rate (ORR) of 63% versus 29% for those treated with chemotherapy.
"One of the greatest challenges in my clinical practice is treating patients at their first metastatic triple negative breast cancer diagnosis who are not candidates for immunotherapy since there has been limited treatment options available," said Zhimin Shao, MD, Director, Fudan University Cancer Institute and Breast Cancer, China, and lead investigator in China of the TROPION-Breast02 trial. "The approval of Datroway in China introduces an important new treatment option, which is supported by clinically meaningful improvements in overall survival and progression-free survival, and offers a significant advancement over the current standard of care."
The safety profile of Datroway (6 mg/kg) was evaluated in 319 patients with TNBC who received Datroway in TROPION-Breast02. The most common (20%) adverse reactions, including laboratory abnormalities, were stomatitis, increased amylase, nausea, alopecia, decreased hemoglobin, decreased white blood cells, constipation, decreased calcium, fatigue, decreased lymphocytes, decreased neutrophils, increased alanine aminotransferase, increased aspartate aminotransferase, dry eye, decreased albumin, vomiting, decreased sodium and increased blood alkaline phosphatase. Serious adverse reactions occurred in 5.6% of patients who received Datroway. Serious adverse reactions in more than 1% of patients who received Datroway included vomiting and anemia. One patient fatality was attributed to interstitial lung disease/pneumonitis.
"Patients with metastatic triple negative breast cancer continue to face a poor prognosis, particularly those who are not eligible for immunotherapy," said Michio Hayashi, China President, Daiichi Sankyo. "As the only TROP2 directed antibody drug conjugate approved in China with an overall survival benefit in this setting, Datroway offers a much-needed treatment option supported by robust clinical evidence for patients facing this aggressive disease. We are proud to bring this innovative medicine to more patients in China."
"There remains a critical need for innovative treatment options that can help improve outcomes based on the aggressive nature of triple negative breast cancer," said Mary Guan, General Manager, China Oncology Business, AstraZeneca. "This second approval for Datroway in China, and the first TROP2 directed antibody drug conjugate approved in this setting, expands its use into triple negative breast cancer and marks another important step in our commitment to addressing the diverse needs of patients across the breast cancer continuum. We will continue to advance innovation and help improve outcomes for more patients living with breast cancer."
Datroway (6 mg/kg) is approved in more than 35 countries/regions, including China, EU, Japan and the U.S. for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. Additional reviews are underway in Australia, Canada, Israel and Switzerland as part of Project Orbis.
About TROPION-Breast02
TROPION-Breast02 is a global, multicenter, randomized, open-label phase 3 trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumors did not express PD-L1 as well as patients with PD-L1 expressing tumors who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrollment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.
The dual primary endpoints of TROPION-Breast02 are OS and PFS as assessed by BICR. Secondary endpoints include PFS as assessed by investigator, ORR, duration of response, disease control rate, pharmacokinetics and safety.
TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.
About Triple Negative Breast Cancer
TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 365,000 diagnoses globally each year.1,2 In China, there are an estimated 56,000 diagnoses of TNBC each year. 1,2 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.3,4,5 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.
While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.3 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.3 For patients with metastatic disease with PD-L1 expressing tumors, the addition of immunotherapy to chemotherapy has improved outcomes in the first-line setting.8,9 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy was the standard first-line treatment. TROP2 is a protein broadly expressed in several solid tumors, including TNBC.11 TROP2 is associated with increased tumor progression and poor survival in patients with breast cancer.
About Datroway
Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using the proprietary DXd ADC Technology of Daiichi Sankyo, Datroway is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.
Datroway (6 mg/kg) is approved in more than 35 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy based on the results from the TROPION-Breast02 trial.
Datroway (6 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.
Datroway (6 mg/kg) is approved in Brazil, Russia, Singapore and the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy, based on the results from TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in a confirmatory trial.
About the Datroway Clinical Development Program
A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The program includes eight phase 3 trials in lung cancer, five phase 3 trials in breast cancer, one phase 3 trial and one phase 2/3 trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings.
(Press release, Daiichi Sankyo, OCT 8, 2026, View Source [SID1234673289])