FDA approves Datroway for HR-positive, HER2-negative breast cancer

The U.S. Food and Drug Administration has approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

The Trop-2-directed antibody and topoisomerase inhibitor conjugate is approved for patients who have had disease progression with prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

The approval was based on a trial in which 732 patients were randomly assigned (1:1) to Datroway (365 participants) or investigator’s choice of chemotherapy (367 participants: eribulin [60%], capecitabine [21%], vinorelbine [10%], or gemcitabine [9%]).

Median progression-free survival was 6.9 months with Datroway versus 4.9 months in the chemotherapy arm (hazard ratio, 0.63; 95% confidence interval, 0.52 to 0.76). Median overall survival did not differ significantly between the groups (18.6 months with Datroway versus 18.3 months with chemotherapy arm; hazard ratio, 1.01; 95% confidence interval, 0.83 to 1.22). The confirmed overall response rates were 36 and 23%, respectively.

The recommended intravenous infusion dose for Datroway is 6 mg/kg (maximum of 540 mg for patients ≥90 kg), administered once every three weeks (21-day cycle), until disease progression or unacceptable toxicity. The most common adverse reactions (≥20%) were stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased alanine aminotransferase, keratitis, increased aspartate aminotransferase, and increased alkaline phosphatase.

Approval of Datroway was granted to Daiichi Sankyo.

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