FDA Grants Priority Review to Datroway for Metastatic Triple Negative Breast Cancer

FDA has accepted the supplemental Biologics License Application (sBLA) for Datroway, granting it Priority Review for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for programmed death-ligand 1 (PD-L1) inhibitor therapy. Datroway could become the standard of care for a patient population where chemotherapy has long been the only approved option, according to the company.¹ FDA typically reserves Priority Review for medicines that demonstrate the potential for significant improvements in safety or efficacy over existing treatments.

How Does this Regulatory Milestone Impact the Clinical Development Landscape?

Approximately 70% of patients with metastatic TNBC are ineligible for immunotherapy due to tumors that do not express PD-L1 or other limiting clinical factors. The sBLA is being reviewed under Project Orbis, an international framework that allows for the concurrent submission and review of oncology medicines among participating global partners. This collaborative regulatory path is intended to expedite the delivery of effective cancer treatments to patients by streamlining the review process across multiple jurisdictions.

Susan Galbraith, executive vice president, Oncology Haematology R&D, AstraZeneca, stated in a press release,¹ “Datroway is the only medicine to significantly improve overall survival compared to chemotherapy in this patient population as demonstrated in the TROPION-Breast02 trial–the results of which are even more striking considering the trial enrolled a subset of patients with highly aggressive disease. The Priority Review of our submission underscores the impact of these results and its review under Project Orbis signals a widely shared commitment to bringing Datroway to patients around the world as quickly as possible.”

A final regulatory decision under the Prescription Drug User Fee Act is anticipated during the second quarter of 2026.

What Clinical and Technical Advancements Support the Potential Approval of this Antibody Drug Conjugate?

Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo. The drug consists of a humanized anti-TROP2 monoclonal antibody attached to topoisomerase I inhibitor payloads via tetrapeptide-based cleavable linkers. In the TROPION-Breast02 Phase III trial,¹ Datroway demonstrated a statistically significant five-month improvement in median overall survival and a 43% reduction in the risk of disease progression or death compared to chemotherapy.

Daiichi Sankyo remains responsible for the global manufacturing and supply of the drug, which utilizes its proprietary DXd ADC technology.

Ken Takeshita, global head, R&D, Daiichi Sankyo, noted in a AstraZeneca press release that,¹ “Datroway potentially could be the first medicine approved in the 1st-line setting to significantly extend overall survival and nearly double the time without disease progression or death compared to chemotherapy in patients with metastatic triple-negative breast cancer for whom immunotherapy was not an option. We are eager to work with the FDA to bring this much needed treatment option to patients with metastatic triple-negative breast cancer.”

Beyond this specific indication, the clinical development program for this ADC now includes more than 20 trials across various solid tumors, reflecting a robust effort to expand the reach of this specialized delivery platform.

How Are Other AstraZeneca Medicines Progressing Through Approval Processes?

In Europe, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended durvalumab for adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. This milestone highlights the expansion of immunotherapy into curative-intent settings where recurrence rates have historically remained high.² If approved, this would be the first immunotherapy-based perioperative regimen for this patient population in the EU.

How Does the Perioperative Regimen Alter the Current Clinical Path?

The regimen utilizes neoadjuvant durvalumab combined with FLOT chemotherapy, followed by adjuvant durvalumab with chemotherapy and subsequent monotherapy.

“Imfinzi plus FLOT demonstrated a durable, increasing long-term survival benefit in the MATTERHORN trial, with more than two-thirds of patients alive at three years. The CHMP recommendation marks further progress toward our goal to offer novel approaches in early-stage cancers where there is the greatest chance for cure and brings us closer to providing the third perioperative Imfinzi EU," Galbraith said in a press release.²

What Clinical Evidence Supports this Regulatory Advancement?

Data from the MATTERHORN Phase III trial indicated a 29% reduction in the risk of disease progression, recurrence, or death.

Josep Tabernero, MD, PhD, head of the Medical Oncology Department at Vall d'Hebron University Hospital, noted in a press release,² “This recommendation signals a major step forward for patients in the EU with early gastric and gastroesophageal junction cancers, who have historically faced high rates of recurrence and poor long-term outcomes despite curative-intent surgery and chemotherapy. This durvalumab-based perioperative regimen is the first immunotherapy approach to significantly extend survival in this setting, and if approved, should set a new standard of care.”

The safety profile of the combination remained consistent with known data for each medicine, and surgical completion rates were comparable to chemotherapy alone.

References

1. AstraZeneca. Datroway Granted Priority Review in the US As 1st-Line Treatment For Patients With Wetastatic Triple-Negative Breast Cancer Who Are Not Candidates For Immunotherapy. Press Release. Feb 3, 2026.
2. AstraZeneca. Imfinzi Perioperative Regimen Recommended For Approval in the EU By CHMP For Patients With Early Gastric and Gastroesophageal Cancers. Press Release. Feb 2, 2026.