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Datroway has been approved for unresectable or metastatic HR+, HER2- breast cancer after endocrine therapy and chemotherapy.
The FDA approved Datroway for unresectable or metastatic HR+, HER2- breast cancer after endocrine therapy and chemotherapy.
The Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan-dlnk) for adults with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease, the agency has announced.
Efficacy of Datroway, a Trop-2-directed antibody and topoisomerase inhibitor conjugate, was determined in the TROPION-Breast01 trial of 732 patients who received Datroway or investigator’s choice of chemotherapy.
Progression-free survival: the time a patient lives without their disease spreading or worsening.
Overall survival: the time a patient lives, regardless of disease status.
Objective response rate: patients who responded partially or completely to treatment.
Stomatitis: swelling and sores in the mouth.
Leukocytes: white blood cells.
Lymphocytes: a type of white blood cell.
Neutrophils: a type of white blood cell.
Keratitis: corneal ulcer.
Median progression-free survival was 6.9 months in the Datroway arm and 4.9 months in the chemotherapy arm, while median overall survival was 18.6 months and 18.3 months, respectively. Confirmed objective response rate was 36% and 23% and the median duration of response was 6.7 months and 5.7 months, respectively.
The most common side effects, occulting in at least 20% of patients, including laboratory abnormalities, included stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased ALT, keratitis, increased AST and increased alkaline phosphatase.
The agency advised that the recommended dosage of Datroway is 6 milligrams per kilogram with a maximum of 540 milligrams for patients 90 kilograms or greater, administered intravenously every three weeks until disease progression or unacceptable toxicity.
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