FDA Approves Datroway for Triple-Negative Breast Cancer

The Food and Drug Administration (FDA) on May 22, 2026, approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor therapy in the U.S. The approval applies to patients with cancer who have not received prior chemotherapy or other systemic anti-cancer therapy for unresectable or metastatic disease.

The decision was based on findings from the phase 3 TROPION-Breast02 trial, which compared Datroway with investigator’s choice of standard chemotherapy in patients with triple-negative breast cancer. The data showed improvements in progression-free survival, overall survival and tumor response rates, offering a new treatment option for a population with limited targeted therapies.

Progression-Free Survival Results in TROPION-Breast02

In the phase 3 TROPION-Breast02 trial, Datroway demonstrated a median progression-free survival of 10.8 months compared with 5.6 months for chemotherapy. Progression-free survival was assessed by blinded independent central review using RECIST v1.1.

The hazard ratio for progression-free survival was 0.57 with a p-value <0.0001, indicating a reduction in the risk of disease progression or death compared with chemotherapy.

Overall Survival Findings

Median overall survival was 23.7 months in the Datroway arm compared with 18.7 months in the chemotherapy arm. The hazard ratio for overall survival was 0.79 with a p-value of 0.0290, supporting an improvement in survival outcomes for patients treated with Datroway.

Tumor Response Rates

Confirmed overall response rate was 64% for Datroway compared with 30% for chemotherapy. This measure reflects the proportion of patients with cancer whose tumors shrank or disappeared during treatment.

Phase 3 TROPION-Breast02 Design

The TROPION-Breast02 trial was a multicenter, open-label, randomized phase 3 study that enrolled 644 patients with unresectable or metastatic triple-negative breast cancer.

Patients had not received prior chemotherapy or other systemic anti-cancer therapy for unresectable or metastatic disease and were not candidates for PD-1 or PD-L1 inhibitor therapy. Patients were excluded if they had a history of interstitial lung disease or pneumonitis requiring steroid treatment, ongoing interstitial lung disease or pneumonitis or clinically significant corneal disease at screening.

Participants were randomized 1 to 1 to receive either Datroway (323 patients) or investigator’s choice of chemotherapy (321 patients). Chemotherapy options included paclitaxel (28%), nab-paclitaxel (54%), capecitabine (2.2%), eribulin (11%) and carboplatin (4.7%).

Randomization was stratified by geographic region, PD-L1 status and disease-free interval history, including de novo disease or intervals of less than or equal 12 months or greater than 12 months.

Key Side Effects and Warnings

Safety findings from the TROPION-Breast02 trial identified several important side effects associated with Datroway. These include interstitial lung disease and pneumonitis, ocular adverse reactions, stomatitis or oral mucositis and embryo-fetal toxicity.

These side effects are included in the prescribing information and require monitoring in patients receiving treatment for unresectable or metastatic triple-negative breast cancer.

Clinical Monitoring Considerations

Healthcare professionals are advised to monitor patients closely for signs and symptoms of interstitial lung disease or pneumonitis due to potential severity. Eye-related adverse reactions and oral inflammation may also occur and require supportive care and management.

Embryo-fetal toxicity is also an important consideration in patients who may become pregnant during treatment.

The application received priority review and used the FDA Assessment Aid to support evaluation.

References

1. “FDA Approves Datroway (datopotamab deruxtecan-dlnk) for unresectable or metastatic triple-negative breast cancer” News Release. U.S. Food and Drug Administration, May 22, 2026

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