Daiichi Sankyo/AstraZeneca’s Datroway Receives US FDA Approval for First-Line Metastatic TNBC, EMA CHMP Gives Positive Opinion

September 13, 2026

Chemistry Today USA

Overview

Datroway (datopotamab deruxtecan), the TROP2-directed DXd ADC co-developed by Daiichi Sankyo and AstraZeneca, has received US FDA approval as a first-line treatment for unresectable or metastatic triple-negative breast cancer (TNBC) patients who are not candidates for PD-1/PD-L1 inhibitors. Additionally, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion, paving the way for European approval. This approval, based on Phase 3 TROPION-Breast02 trial results, offers a crucial new first-line treatment option for TNBC patients.

In Depth

Key Findings

Datroway (datopotamab deruxtecan), a TROP2-directed antibody-drug conjugate (ADC) co-developed by Daiichi Sankyo and AstraZeneca, has received U.S. FDA approval as a first-line treatment for patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors. Furthermore, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Datroway, marking a significant step towards its approval within the European Union (EU).

Technical and Clinical Details

Datroway is an ADC that targets TROP2 (trophoblast cell-surface antigen 2), a protein commonly expressed on the surface of tumor cells. It utilizes a proprietary DXd linker system to conjugate a potent topoisomerase I inhibitor, deruxtecan. This design enables the drug to specifically deliver the cytotoxic payload to TROP2-positive cancer cells, releasing the therapeutic agent intracellularly to exert its anti-tumor effects. The U.S. approval is supported by data from the Phase 3 TROPION-Breast02 trial, which demonstrated a statistically significant improvement in progression-free survival (PFS) and objective response rate (ORR) for Datroway compared to standard chemotherapy in patients with unresectable or metastatic TNBC who had no prior exposure to PD-1/PD-L1 inhibitors. The safety profile was manageable, presenting a differentiated toxicity profile compared to conventional chemotherapy, and was generally well-tolerated by patients. The CHMP’s positive opinion further reinforces these clinical benefits.

Background & Context

Triple-negative breast cancer is characterized by the absence of estrogen receptors, progesterone receptors, and HER2 expression, leading to limited treatment options and a particularly poor prognosis in its metastatic form. Historically, first-line treatment for TNBC has been restricted, with PD-1/PD-L1 inhibitors applicable only to a subset of patients, leaving a significant unmet medical need for other patient populations. The approval of Datroway addresses this critical gap, highlighting the potential for TROP2-targeting ADCs to establish a new foundation in TNBC therapy. This event underscores the evolution of ADC technology and the expansion of its clinical applications.

Strategic Significance & Outlook

The US FDA approval and EMA CHMP positive opinion for Datroway provide a powerful new treatment option for patients with metastatic TNBC, with the potential to alter the standard of care. Its applicability to patients not eligible for PD-1/PD-L1 inhibitors offers a clear advantage for a population with historically few treatment choices. Accelerated formal approval in Europe is now expected, alongside rapid progression of regulatory submissions in other regions. Datroway’s success also suggests that TROP2 ADCs could play a crucial role in treating other TROP2-expressing solid tumors, such as lung cancer, further enhancing the strategic value of Daiichi Sankyo and AstraZeneca’s oncology pipelines.

Source: https://www.chemistry-today.com/datroway-approved-in-the-us-as-first-trop2-directed-antibody-drug-conjugate-for-1st-line-treatment-of-patients-with-metas-tic-triple-negative-breast-cancer-who-are-not-pd-1-pd-l1-inhibitor-candidates/

Get our weekly technology intelligence — free

Receive an infographic that lets you judge at a glance whether each field’s analysis report is worth reading.

Subscribe Free — Weekly Tech Intelligence

By subscribing, you’ll receive Troy-Technical’s weekly technology intelligence newsletter.