FDA Approves Datopotamab Deruxtecan for Patients With Triple-Negative Breast Cancer

Clinical Summary:

• Based on results from the phase 3 TROPION-Breast02 trial, the FDA has approved datopotamab deruxtecan for patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor therapy.
• In this randomized, open-label study, datopotamab deruxtecan improved progression-free survival, overall survival, and objective response rate compared with investigator’s choice chemotherapy, with a safety profile consistent with prior experience with the agent. 
• This approval provides a new treatment option for patients with advanced triple-negative breast cancer who have limited therapeutic options outside of immunotherapy.

On May 22, 2026, the US Food and Drug Administration (FDA) approved datopotamab deruxtecan (Datroway, Daiichi Sankyo, Inc.) for the treatment of patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor therapy. This approval was based on results from the phase 3 TROPION-Breast02 trial.

In this multicenter, open-label trial,  644 patients who were not candidates for treatment with either a PD-1 or PD-L1 inhibitor and had not received prior chemotherapy or other systemic anticancer therapy for advanced disease were randomized 1:1 to receive either datopotamab deruxtecan (n = 323) or investigator’s choice chemotherapy (n = 321), including paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin. Exclusion criteria included ILD or pneumonitis requiring steroids, ongoing ILD or pneumonitis, or clinically significant corneal disease. 

Primary end points included progression-free survival (PFS) and overall survival (OS). A key secondary end point was confirmed overall response rate (ORR). 

At analysis, the median PFS was 10.8 months in the datopotamab deruxtecan arm and 5.6 months in the chemotherapy arm (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.47 to 0.69; P < .0001). The median OS was 23.7 months and 18.7 months, respectively (HR, 0.79; 95% CI, 0.64 to 0.98; P = .0290). The confirmed ORR was 64% in the datopotamab deruxtecan arm and 30% in the chemotherapy arm.

The recommended dose of datopotamab deruxtecan is 6 mg/kg (up to a maximum dose of 540 mg for patients weighing ≥90 kg) administered intravenously once every 3 weeks in 21-day cycles until disease progression or unacceptable toxicity. 

The prescribing information includes warnings and precautions for ILD and pneumonitis, ocular adverse reactions, stomatitis/oral mucositis, and embryo-fetal toxicity.

Source:

US Food and Drug Administration. FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer. Accessed on May 22, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer