FDA Alert

FDA Approves Datopotamab Deruxtecan-dlnk (Datroway) for Unresectable or Metastatic Triple-Negative Breast Cancer

Edited by:
Anthony Calabro, MA

Key Highlights

  • FDA approved datopotamab deruxtecan-dlnk for adults with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.
  • Approval was supported by TROPION-Breast02, a multicenter, open-label, randomized trial of 644 patients.
  • Median progression-free survival was 10.8 months with datopotamab deruxtecan-dlnk vs 5.6 months with investigator’s choice of chemotherapy.
  • The recommended dose is 6 mg/kg by intravenous infusion once every 3 weeks until disease progression or unacceptable toxicity.

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 (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

The approval was based on results from TROPION-Breast02, a multicenter, open-label, randomized trial of 644 patients with unresectable or metastatic TNBC. Patients in the trial had not received prior chemotherapy or other systemic anticancer therapy for unresectable or metastatic breast cancer and were not candidates for PD-1/PD-L1 inhibitor therapy. Median progression-free survival was 10.8 months with datopotamab deruxtecan-dlnk vs 5.6 months with investigator’s choice of chemotherapy, respectively (hazard ratio [HR], 0.57; 95% CI, 0.47-0.69; P <.0001). Median overall survival was 23.7 months vs 18.7 months, respectively (HR, 0.79; 95% CI, 0.64-0.98; P = .0290). Confirmed overall response rates were 64% and 30%, respectively.

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

The recommended dose of datopotamab deruxtecan-dlnk is 6 mg/kg, up to a maximum of 540 mg for patients weighing at least 90 kg, administered as an intravenous infusion once every 3 weeks in a 21-day cycle until disease progression or unacceptable toxicity.

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