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How many new adverse effects will be identified for Datopotamab Deruxtecan by end of 2025?
2
Resolution / Starting Odds
None • 25%
1 to 2 • 25%
3 to 4 • 25%
More than 4 • 25%
FDA safety communications and clinical trial publications
Story
FDA Approves Datopotamab Deruxtecan With Improved PFS for Advanced HR+/HER2- Breast Cancer
Jan 17, 2025, 12:23 PM
The FDA has approved datopotamab deruxtecan (Datroway) for the treatment of unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer in adults who have previously received endocrine-based therapy and chemotherapy. The approval is supported by the TROPION-Breast01 trial, which showed a median progression-free survival of 6.9 months for Datroway compared to 4.9 months for chemotherapy (HR, 0.63). The trial also reported a median overall survival of 18.6 months for Datroway versus 18.3 months for chemotherapy. Common adverse effects included stomatitis, nausea, and fatigue. Datopotamab deruxtecan is co-developed by AstraZeneca and Daiichi Sankyo, marking a significant advancement in targeted cancer therapies.
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Two • 25%
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VIR-5818 higher ORR • 25%