The European Commission approves Datroway (datopotamab deruxtecan) for first-line metastatic TNBC in patients ineligible for immunotherapy, based on Phase 3 TROPION-Breast02 results.
Written By: Kalyani Boharapi,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
The European Commission (EC) has approved Datroway (datopotamab deruxtecan) as monotherapy for the first-line treatment of adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval makes Datroway the first and only TROP2-directed antibody-drug conjugate (ADC) in the European Union to demonstrate an overall survival benefit in the first-line metastatic TNBC setting.
The decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and is based on results from the global Phase 3 TROPION-Breast02 trial.
New Treatment Option for Patients with Limited Choices
Triple-negative breast cancer is one of the most aggressive breast cancer subtypes and is associated with poor outcomes. Although immunotherapy has improved survival for some patients, many are not eligible because of PD-L1-negative disease, prior immunotherapy exposure, contraindications, or limited treatment access. For these patients, chemotherapy has remained the standard first-line treatment.
Datroway targets TROP2, a protein highly expressed in many solid tumors, including TNBC, where it is associated with tumor progression and poor survival.
Phase 3 Trial Demonstrated Survival Benefit
The randomized, open-label TROPION-Breast02 trial (NCT05374512) enrolled 644 patients with previously untreated unresectable or metastatic TNBC who were not candidates for immunotherapy. Participants received either Datroway or investigator’s choice of chemotherapy.
The study met both dual primary endpoints, demonstrating statistically significant improvements in overall survival (OS) and progression-free survival (PFS).
Median overall survival was 23.7 months with Datroway compared with 18.7 months for chemotherapy, representing a 5-month improvement (HR 0.79; P=0.0291). Datroway also reduced the risk of disease progression or death by 43% (HR 0.57; P<0.0001) and achieved a higher objective response rate of 62.5% versus 29.3% with chemotherapy.
The safety profile was consistent with previous Datroway breast cancer studies, with no new safety signals reported.
Clinical and Regulatory Significance
Based on the TROPION-Breast02 results, Datroway has been incorporated into the European Society for Medical Oncology (ESMO) Clinical Practice Guidelines as a Category IA first-line treatment option for patients with metastatic TNBC who are not candidates for immunotherapy. It is also the preferred option for patients whose disease recurs within six months after completing adjuvant therapy and received an ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) score of 4 out of 5.
Datroway received US FDA approval for the same indication in May 2026, while regulatory reviews remain ongoing in China, Japan, Australia, Canada, Singapore, and Switzerland through Project Orbis.
About Datroway
Datroway (datopotamab deruxtecan) is a TROP2-directed ADC developed using Daiichi Sankyo’s proprietary DXd technology. It combines a humanized anti-TROP2 monoclonal antibody with a topoisomerase I inhibitor payload linked by a cleavable linker to deliver targeted anti-cancer therapy.
The medicine is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. It is approved in more than 45 countries and regions for certain patients with HR-positive, HER2-negative metastatic breast cancer and in more than 30 countries and regions for patients with metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.
Future Development
The EC approval provides a new evidence-based first-line treatment option for patients with metastatic TNBC who cannot receive immunotherapy. Supported by robust Phase 3 data showing improvements in overall survival and progression-free survival, Datroway expands treatment options for an aggressive disease with historically limited therapeutic choices.
Datroway continues to be evaluated in a global clinical development program comprising more than 20 studies across multiple cancers, including non-small cell lung cancer, breast cancer, and urothelial cancer, with several Phase 3 trials exploring its use as both monotherapy and combination therapy.
What This Means for Patients
For patients with metastatic TNBC who cannot receive immunotherapy, treatment options have historically been limited. The EU approval of Datroway introduces a therapy that has demonstrated an overall survival benefit in a setting where improving long-term outcomes remains challenging.
As the first TROP2-directed antibody-drug conjugate (ADC) approved in the European Union to demonstrate an overall survival benefit in the first-line metastatic TNBC setting, Datroway expands treatment options for patients facing this aggressive form of breast cancer.
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About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.