Loading...
Loading...
Browse all stories on DeepNewz
VisitWill Datopotamab Deruxtecan show improved overall survival in new trial by end of 2025?
Yes • 50%
No • 50%
Publication of clinical trial results in a peer-reviewed journal
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.
View original story
Trial stopped early for safety concerns • 25%
Significant survival improvement • 25%
No significant survival improvement • 25%
Trial stopped early for efficacy • 25%
No • 50%
Yes • 50%
Yes • 50%
No • 50%
No Change • 25%
Significant Improvement • 25%
Moderate Improvement • 25%
Worse Outcomes • 25%
Other outcome • 25%
Negative results halting development • 25%
Neutral results requiring further study • 25%
Positive results leading to Phase 2 • 25%
VIR-5818 higher ORR • 25%
Same ORR • 25%
Data not available • 25%
Enhertu higher ORR • 25%
Full Approval • 25%
No Approval • 25%
Conditional Approval • 25%
Accelerated Approval • 25%
Negative efficacy and safety concerns • 25%
Positive efficacy and safety results • 25%
Positive efficacy, but safety concerns • 25%
Negative efficacy, but good safety • 25%
Two • 25%
None • 25%
More than two • 25%
One • 25%
More than 4 • 25%
3 to 4 • 25%
None • 25%
1 to 2 • 25%