FDA Approves Datroway for HR-Positive, HER2-Negative Breast Cancer
By Lori Solomon HealthDay Reporter
FRIDAY, Jan. 31, 2025 -- 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 percent], capecitabine [21 percent], vinorelbine [10 percent], or gemcitabine [9 percent]). Median progression-free survival was 6.9 months with Datroway versus 4.9 months in the chemotherapy arm (hazard ratio, 0.63; 95 percent 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 percent confidence interval, 0.83 to 1.22). The confirmed overall response rates were 36 and 23 percent, 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 percent) 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.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted January 2025
Read this next
Breast Cancer Incidence Trends Vary by Age
TUESDAY, July 1, 2025 -- Breast cancer incidence trends differ by age, even among older women, particularly by race and ethnicity and stage at diagnosis, according to a study...
Lower Risk of Alzheimer Disease Seen for Breast Cancer Survivors
MONDAY, June 30, 2025 -- Breast cancer survivors have a lower risk of Alzheimer disease (AD) compared with cancer-free controls, according to a study published online June 20 in...
BRCA Mutations Linked to Breast Implant Anaplastic Large Cell Lymphoma
WEDNESDAY, June 25, 2025 -- For women with breast cancer (BC), BRCA mutations are associated with increased risk of developing breast implant–associated anaplastic large...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.