WILMINGTON, Del. — AstraZeneca and Daiichi Sankyo said the U.S. Food and Drug Administration has approved DATROWAY for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor therapy.
DATROWAY, also known as datopotamab deruxtecan-dlnk, is a TROP2-directed antibody drug conjugate. The companies said it is the first TROP2-directed antibody drug conjugate approved in the U.S. for first-line treatment of this patient population.
The approval followed Priority Review and was based on results from the Phase III TROPION-Breast02 trial, which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology.
“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,” said Tiffany A. Traina, MD, FASCO, Section Head, Triple-Negative Breast Cancer Clinical Research Program, Memorial Sloan Kettering Cancer Center and investigator for TROPION-Breast02.
Triple-negative breast cancer is an aggressive form of breast cancer that can be difficult to treat, particularly for patients with metastatic disease who are not candidates for immunotherapy. The companies said DATROWAY is the only TROP2-directed antibody drug conjugate to show an overall survival benefit in this setting compared with chemotherapy.
“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,” said Arlene Brothers, Executive Director, Triple Negative Breast Cancer Foundation.
In TROPION-Breast02, DATROWAY showed a statistically significant and clinically meaningful 5-month improvement in median overall survival compared with chemotherapy. The treatment had a hazard ratio of 0.79 for overall survival and reduced the risk of disease progression or death by 43%, with a hazard ratio of 0.57.
DATROWAY also produced stronger tumor responses, with an objective response rate of 64% compared with 30% for chemotherapy. The companies said the drug’s safety profile in the trial was consistent with previous DATROWAY breast cancer studies.
“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,” said Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca.
“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,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc.
The application was reviewed under Project Orbis, an FDA Oncology Center of Excellence initiative that allows concurrent review of oncology medicines among participating international regulators. Reviews are ongoing in Australia, Canada, Singapore and Switzerland, with additional reviews underway in the European Union, China and Japan.
The companies said DATROWAY has also been included in the NCCN Clinical Practice Guidelines in Oncology as a Category 1 preferred first-line treatment option for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy.
DATROWAY was discovered by Daiichi Sankyo and is being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
