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AstraZeneca/Daiichi Sankyo reapply for EU approval of Dato-DXd by end of 2025?
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European Medicines Agency announcements or AstraZeneca/Daiichi Sankyo press releases
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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AstraZeneca, in collaboration with Daiichi Sankyo, has voluntarily withdrawn its marketing authorization application for the lung cancer drug datopotamab deruxtecan ($Dato-DXd) from the European Union's medicines regulator.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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