New phase III trial for Dato-DXd in lung cancer announced by mid-2025?
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Press releases from AstraZeneca or Daiichi Sankyo
AstraZeneca and Daiichi Sankyo Withdraw EU Application for Lung Cancer Drug Datopotamab Deruxtecan Due to Non-Significant Survival Improvement
Dec 24, 2024, 11:37 AM
AstraZeneca, in collaboration with Daiichi Sankyo, has voluntarily withdrawn its marketing authorization application for the lung cancer drug datopotamab deruxtecan ($Dato-DXd) from the European Union's medicines regulator. The decision follows feedback from the European Medicines Agency after trial results from the phase advanced study TROPION-Lung01 showed that the drug did not significantly improve patient survival rates. The drug, also known as Dato-DXd, had previously received the designation of innovative therapy from the U.S. Food and Drug Administration earlier this month for its results in treating a specific type of lung cancer. Dato-DXd belongs to a promising group of treatments known as antibody-drug conjugates.
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No • 50%
Yes • 50%
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Yes • 50%
Yes • 50%
No • 50%
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Yes • 50%
Negative results halting development • 25%
Other outcome • 25%
Positive results leading to Phase 2 • 25%
Neutral results requiring further study • 25%
Positive efficacy, but safety concerns • 25%
Negative efficacy, but good safety • 25%
Negative efficacy and safety concerns • 25%
Positive efficacy and safety results • 25%
AstraZeneca/Daiichi Sankyo • 25%
Roche • 25%
Pfizer • 25%
Other • 25%
No action • 25%
Reapplication for approval • 25%
Approval in a different indication • 25%
Complete withdrawal from EU market • 25%