FDA approved AstraZeneca and Daiichi Sankyo’s Datroway for first-line metastatic triple-negative breast cancer.

The approval is for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy, expanding treatment options in a difficult-to-treat patient population with historically limited alternatives beyond chemotherapy.

What is Datroway’s approval based on?

Datroway’s approval was granted under Priority Review and is based on results from the Phase III Tropion-Breast02 trial, which demonstrated significant improvements in overall survival and progression-free survival compared with chemotherapy in the first-line metastatic setting.^1,2

The decision positions Datroway as the first antibody-drug conjugate (ADC) to show a median overall survival of two years in first-line metastatic TNBC, further strengthening the growing role of ADCs across solid tumor oncology.²

“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,” said Tiffany A. Traina, MD, FASCO, of Memorial Sloan Kettering Cancer Center and an investigator for the study.

Datroway is a TROP2-directed DXd ADC designed to selectively deliver chemotherapy payloads to cancer cells expressing the TROP2 protein.¹

FDA’s approval of Datroway marks the third US indication for Datroway and the second in breast cancer, highlighting the companies’ plans to expand the ADC’s use across multiple tumor types and treatment settings.¹

What did the trial data show?

In the trial, Datroway reduced the risk of disease progression or death by 43% versus chemotherapy and improved median overall survival by five months.¹ The therapy also produced a substantially higher objective response rate, with 64% of patients responding to treatment compared with 30% in the chemotherapy arm.

The safety profile observed in Tropion-Breast02 remained consistent with previous Datroway studies in breast cancer, according to the companies.¹

Triple-negative breast cancer remains one of the most aggressive breast cancer subtypes, accounting for approximately 10% to 15% of breast cancer diagnoses.¹ Patients with metastatic disease who cannot receive immunotherapy have faced especially limited treatment options, making the approval potentially significant for clinical practice.

“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,” said Arlene Brothers, executive director of the Triple Negative Breast Cancer Foundation.

Why is the approval important?

Datroway’s approval also reinforces AstraZeneca and Daiichi Sankyo’s broader oncology strategy centered on antibody-drug conjugates, an increasingly competitive area of cancer drug development.

“Triple-negative breast cancer is notoriously difficult to treat,” said Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Haematology Business Unit. “With today’s approval, we are proud to bring Datroway to a broad population of advanced triple-negative breast cancer patients.”

The application was reviewed under the FDA’s Project Orbis initiative, which coordinates international regulatory reviews of oncology therapies. As of May 22, 2026, regulatory reviews are still ongoing in multiple markets, including the EU, China, Japan, Australia, Canada, Singapore, and Switzerland.¹

Following the trial results, Datroway was also added to the NCCN Clinical Practice Guidelines as a Category 1 preferred first-line treatment option for metastatic TNBC patients who are not candidates for immunotherapy.¹

Sources

1. DATROWAY® (datopotamab deruxtecan-dlnk) approved in the US as first TROP2-directed antibody drug conjugate for 1st-line treatment of patients with metastatic triple-negative breast cancer who are not PD-1/PD-L1 inhibitor candidates AstraZeneca May 22, 2026 https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/DATROWAY-datopotamab-deruxtecan-dlnk-approved-in-the-US-as-first-TROP2-directed-antibody-drug-conjugate-for-1st-line-treatment-of-patients-with-metastatic-triple-negative-breast-cancer-who-are-not-PD-1-PD-L1-inhibitor-candidates.html
2. DATROWAY® (datopotamab deruxtecan-dlnk) granted Priority Review in the US as 1st-line treatment for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy AstraZeneca February 3, 2026 https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/DATROWAY-datopotamab-deruxtecan-dlnk-granted-Priority-Review-in-the-US-as-1st-line-treatment-for-patients-with-metastatic-triple-negative-breast-cancer-who-are-not-candidates-for-immunotherapy.html