DATROWAY approved as the first TROP2 directed antibody drug conjugate for first line treatment of patients with metastatic triple negative breast cancer who are not PD-1/PD-L1 inhibitor candidates

AstraZeneca and Daiichi Sankyo’s DATROWAY has been approved in the US for the treatment of adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. DATROWAY is the only TROP2 directed antibody drug conjugate shown to prolong overall survival in this setting versus chemotherapy, with a median overall survival of approximately two years based on the TROPION-Breast02 Phase III trial.

The approval follows Priority Review by the Food and Drug Administration based on results from TROPION-Breast02, which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology.

Tiffany A. Traina, MD, FASCO, Section Head, Triple-Negative Breast Cancer Clinical Research Program, Memorial Sloan Kettering Cancer Center, and investigator for TROPION-Breast02, said: “Datopotamab deruxtecan is the first and only medicine to significantly prolong overall survival in the 1st-line setting compared to chemotherapy in patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy. This approval will bring a much-needed treatment option for these patients.”

Arlene Brothers, Executive Director, Triple Negative Breast Cancer Foundation, said: “For seven out of 10 patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy, chemotherapy has remained the only treatment option. Today’s approval of DATROWAY means that for the first time, these patients will have a new standard of care beyond traditional chemotherapy at the outset of their treatment.”

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “Triple-negative breast cancer is notoriously difficult to treat. Patients with metastatic disease, especially those who are unable to receive immunotherapy, urgently need more effective, durable and tolerable treatment options, which extend survival. With today’s approval, we are proud to bring DATROWAY to a broad population of advanced triple-negative breast cancer patients and we continue to study its promise as a mainstay treatment across tumors, stages and settings.”

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc., said: “As the first antibody drug conjugate to demonstrate a median overall survival of two years in the 1st-line metastatic setting of triple-negative breast cancer, DATROWAY has the potential to redefine the treatment landscape for these patients. With this approval, DATROWAY is now approved for three indications in the US, including two for breast cancer, underscoring its potential to play an important role across tumor types.”

In the trial, DATROWAY delivered a statistically significant and clinically meaningful 5.0 month improvement in median overall survival (hazard ratio 0.79; 95% confidence interval 0.64 to 0.98; p=0.0290) and a 43% reduction in patients’ risk of disease progression or death (hazard ratio 0.57; 95% confidence interval 0.47 to 0.69; p<0.0001) compared with chemotherapy as first line treatment in this patient population. DATROWAY was also linked to stronger treatment responses, including an objective response rate of 64% compared with 30% on chemotherapy. The safety profile of DATROWAY in TROPION-Breast02 was consistent with previous clinical trials of the medicine in breast cancer.

The application was reviewed under Project Orbis, a framework for concurrent submission and review of oncology medicines among participating international partners, with the aim of bringing effective cancer treatments to patients as early as possible. As part of Project Orbis, reviews are ongoing in Australia, Canada, Singapore, and Switzerland, with additional reviews underway in the EU, China, and Japan.

Based on the TROPION-Breast02 results, datopotamab deruxtecan has been included in the NCCN Clinical Practice Guidelines in Oncology as a Category 1 Preferred first line treatment option for patients with metastatic TNBC who are not candidates for immunotherapy.

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Related Topics and Keywords

Datroway, metastatic triple-negative breast cancer, PD-1/PD-L1 inhibitor candidates, TROP2