Landmark Approval: Datopotamab Deruxtecan Approval in China, Signaling a Major Shift in Breast Cancer Treatment Landscape
China’s breast cancer treatment landscape has reached a new milestone with the regulatory approval of the globally innovative antibody–drug conjugate Datopotamab Deruxtecan (Datroway).
Official Approval: Defined Indication and Clinical Positioning
On August 22, 2025, the National Medical Products Administration (NMPA) granted formal market approval to Datopotamab Deruxtecan (Datroway) for the treatment of patients with advanced HR+/HER2− breast cancer whose disease has progressed following endocrine therapy and chemotherapy.
“This represents a transformative juncture in the management of advanced breast cancer in China,” stated Hong Kong DengYue Medicine.
The Datopotamab Deruxtecan approval provides a crucial new therapeutic avenue for patients who previously faced limited options and a challenging prognosis after exhausting standard lines of therapy.
It also reflects China’s continued efforts to accelerate patient access to globally validated breakthrough oncology treatments.
✨ The transition of Datopotamab Deruxtecan from priority review to full approval underscores the NMPA’s evolving regulatory framework, aimed at aligning domestic oncology care more closely with global innovation timelines.
Foundational Evidence: Global Phase III Data with Chinese Contribution
The cornerstone of this approval is the robust data from the global, multicenter, Phase III TROPION-Breast01 trial.
This study demonstrated that Datopotamab Deruxtecan provided a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to the investigator’s choice of standard chemotherapy (capecitabine, gemcitabine, eribulin, or vinorelbine).
Critically, this global trial included a Chinese patient cohort.
The consistency of the efficacy and safety data from Chinese participants with the overall study population provided direct and compelling evidence supporting the Datopotamab deruxtecan efficacy profile for patients in China, ensuring the approval is grounded in locally relevant clinical evidence.
Understanding the Mechanism: A Precision TROP2-Targeted ADC
Datopotamab deruxtecan structure is designed for precision.
It is an ADC targeting TROP2, a cell surface protein highly expressed across various solid tumors, including HR+/HER2- breast cancer.
- Precision Targeting: The humanized monoclonal antibody component specifically binds to TROP2 on tumor cells.
- Efficient Delivery: A stable, cleavable linker connects the antibody to the cytotoxic Datopotamab Deruxtecan payload.
- Potent Anti-Tumor Activity: Upon internalization, the payload—a potent topoisomerase I inhibitor derivative called DXd—is released intracellularly. It induces DNA damage and cell death.
Notably, the membrane-permeable nature of the payload allows for a potent “bystander effect,” eliminating neighboring tumor cells and addressing tumor heterogeneity.
Administration and Future Outlook
The recommended Datopotamab deruxtecan dose is 6 mg/kg administered via intravenous infusion every three weeks.
Treatment continues until disease progression or unacceptable toxicity, with dosing adjustments or delays managed per protocol based on tolerability.
The approval for HR+/HER2- breast cancer is a significant first step, with broader potential on the horizon:
- Expansion in Breast Cancer: A regulatory submission for unresectable or metastatic triple-negative breast cancer (TNBC) (based on the TROPION-Breast02 trial) is currently under review in China, potentially extending this innovative therapy to a patient population with even fewer effective options.
- Potential in Lung Cancer: The drug has also shown remarkable success in advanced non-small cell lung cancer (NSCLC) in global studies, with a submission for this indication in China anticipated in the near future.
- Earlier-Stage Exploration: Investigations are actively underway in the adjuvant setting for early breast cancer (e.g., TROPION-Breast03), aiming to move this effective treatment earlier in the disease course to improve cure rates.
With the formal Datopotamab Deruxtecan approval, the drug will gradually become available in major hospitals nationwide. We advise patients and caregivers:
- Prescription and Use: Datopotamab Deruxtecan is a prescription-only medication. It must be used under the strict supervision and guidance of a qualified oncologist, who will determine its suitability based on a comprehensive assessment of the patient’s specific condition, prior treatment history, and overall health status.
- Safety Management: Common adverse reactions include stomatitis, nausea, vomiting, and fatigue, which are generally manageable with prophylactic measures and supportive care. Vigilance for serious adverse effects such as interstitial lung disease (ILD)/pneumonitis is crucial. New or worsening respiratory symptoms like cough or dyspnea require immediate medical attention.
- Information Sources: Patients should seek information through official medical institutions and channels. Procuring medications from unauthorized sources is strongly discouraged.
The approval of Datopotamab Deruxtecan is a powerful testament to China’s entry into a new era of precision ADC therapy for advanced breast cancer.
Dengyue Medicine remains committed to its professional mission, continuously monitoring and reporting on the real-world application and data of such innovative treatments, providing objective and cutting-edge information to support both healthcare professionals and patients
