FDA Approves Datopotamab deruxtecan-dlnk for First-Line Metastatic TNBC

Background and regulatory decision

On May 22, 2026, the FDA approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor therapy. The approval applies to patients who have not received prior chemotherapy or other systemic anti-cancer therapy for unresectable or metastatic disease.

Efficacy results from TROPION-Breast02

Efficacy was evaluated in the phase 3 TROPION-Breast02 trial (NCT05374512), which enrolled 644 patients randomized 1:1 to datopotamab deruxtecan-dlnk (n=323) or investigator’s choice of chemotherapy (n=321).

Median progression-free survival was 10.8 months versus 5.6 months with chemotherapy, respectively (hazard ratio 0.57; 95% CI: 0.47-0.69; P <0.0001).

Median overall survival was 23.7 months versus 18.7 months (hazard ratio 0.79; 95% CI: 0.64-0.98; P = 0.0290).

Confirmed overall response rate was 64% versus 30%, respectively.

Study design and patient population

The multicenter, open-label trial enrolled patients with unresectable or metastatic triple-negative breast cancer who had not received prior systemic therapy for metastatic disease and were not candidates for PD-1 or PD-L1 inhibitors.

Patients were excluded for prior interstitial lung disease or pneumonitis requiring steroids, ongoing interstitial lung disease or pneumonitis or clinically significant corneal disease at screening.

Chemotherapy comparator options included paclitaxel (28%), nab-paclitaxel (54%), capecitabine (2.2%), eribulin (11%) and carboplatin (4.7%).

Safety profile and dosing

Warnings and precautions include interstitial lung disease and pneumonitis, ocular adverse reactions, stomatitis or oral mucositis and embryo-fetal toxicity.

The recommended dose is 6 mg/kg (up to 540 mg for patients ≥90 kg) administered intravenously every three weeks until disease progression or unacceptable toxicity.

Regulatory notes

The review was conducted under Project Orbis with participation from multiple international regulatory agencies. The application received priority review and used the FDA Assessment Aid to support evaluation.

References

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