FDA Approves Datroway for Pretreated Advanced Breast Cancer

The FDA approved datopotamab deruxtecan (Datroway) for adults with unresectable or metastatic, hormone receptor (HR)-positive/HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Efficacy of the Trop2-directed antibody and topoisomerase inhibitor conjugate was evaluated in the multicenter TROPION-Breast01 trial, which included 732 patients randomized to datopotamab deruxtecan or investigator’s choice of chemotherapy. Participants must have experienced disease progression, been ineligible for further endocrine therapy, and received one or two prior lines of chemotherapy for unresectable or metastatic disease.

The trial met its primary endpoint, with a median progression-free survival (PFS) of 6.9 months in the datopotamab deruxtecan arm versus 4.9 months in the chemotherapy arm (HR 0.63, 95% CI 0.52-0.76, P

However, datopotamab deruxtecan failed to improve overall survival (OS), with a median OS of 18.6 months and 18.3 months, respectively (HR 1.01, 95% CI 0.83-1.22).

The confirmed overall response rate was 36% in the datopotamab arm and 23% in the chemotherapy arm, while median duration of response was 6.7 months and 5.7 months, respectively.

Common adverse events (≥20%) included stomatitis; nausea; fatigue; decreases in leukocytes, calcium, lymphocytes, neutrophils, and hemoglobin; alopecia; constipation; dry eye; vomiting; keratitis; and increases in alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase.

The recommended dose of datopotamab deruxtecan is 6 mg/kg (maximum of 540 mg for patients ≥90 kg), administered as an intravenous infusion once every 3 weeks until disease progression or unacceptable toxicity.