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The FDA has approved datopotamab deruxtecan (Dato-DXd, Datroway, Daiichi Sankyo) 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.

The approval marks the second breast cancer indication in the US for the Trop-2-directed antibody and topoisomerase inhibitor conjugate. The agent, which also has lung cancer indications, was first approved for breast cancer in January 2025 for previously treated patients with unresectable or metastatic HR-positive, HER2-negative disease. It is being jointly developed and commercialized with AstraZeneca.

Approval for the new breast cancer indication followed priority review and was based on findings from the randomized, open-label TROPION-Breast02 trial, which were presented at the 2025 European Society for Medical Oncology Congress and published in the Annals of Oncology.

The trial involved 644 patients with unresectable or metastatic triple-negative breast cancer who had not received prior chemotherapy or systemic anticancer therapy and who were not candidates for PD-1/PD-L1 inhibitor therapy.

Median progression-free survival was nearly doubled with Dato-DXd, at 10.8 months vs 5.6 months among patients randomly assigned to receive investigator’s choice of chemotherapy (hazard ratio [HR], 0.57).

Median overall survival was 23.7 months vs 18.7 months in the treatment arms, respectively (HR, 0.79), and the confirmed objective response rate was 64% vs 30%.

The recommended Dato-DXd dose is 6 mg/kg, and up to a maximum of 540 mg for patients weighing at least 90 kg. The treatment is administered by intravenous infusion once every 3 weeks until disease progression or unacceptable toxicity.

The prescribing information, which includes warnings and precautions for interstitial lung disease and pneumonitis, ocular adverse reactions, stomatitis/oral mucositis, and embryo-fetal toxicity, will be posted on Drugs@FDA.

“Datopotamab deruxtecan is the first and only medicine to significantly prolong overall survival in the first-line setting compared to chemotherapy in patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy,” trial investigator Tiffany A. Traina, MD, of Memorial Sloan Kettering Cancer Center in New York City, said in a company press release.

“This approval will bring a much-needed treatment option for these patients,” she said.

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on X: @SW_MedReporter.