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Will Datopotamab Deruxtecan be approved for another cancer type by end of 2025?
2
Resolution / Starting Odds
Yes • 50%
No • 50%
FDA announcements and press releases
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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Similar markets
No • 50%
Yes • 50%
Trial stopped early for safety concerns • 25%
No significant survival improvement • 25%
Significant survival improvement • 25%
Trial stopped early for efficacy • 25%
One • 25%
None • 25%
Two • 25%
Three or more • 25%
No Approval • 25%
Full Approval • 25%
Accelerated Approval • 25%
Conditional Approval • 25%
No • 50%
Yes • 50%
