AZN Withdraws EU Application for Lung Cancer Drug After Feedback

AstraZeneca (AZN, Financial) and Daiichi Sankyo have voluntarily withdrawn their marketing authorization application (MAA) for datopotamab deruxtecan (Dato-DXd) in the European Union. The drug was intended for the treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). This decision followed feedback from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The companies initially sought EU approval for this antibody-drug conjugate based on data from their TROPION-Lung01 Phase 3 trial. Although the trial met its primary endpoint of progression-free survival, it did not achieve the dual primary endpoint of overall survival with statistical significance. In November, AstraZeneca and Daiichi Sankyo also withdrew their U.S. marketing application for Dato-DXd in NSCLC, opting instead to seek FDA accelerated approval for its use in EGFR-mutated NSCLC.

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