AstraZeneca and Daiichi Sankyo Voluntarily Withdraw EU Application

In a recent joint announcement, AstraZeneca and Daiichi Sankyo have decided to withdraw their marketing authorization application (MAA) for datopotamab deruxtecan (Dato-DXd) in the European Union. The decision was made voluntarily, reflecting the companies' assessment of the current data available for this advanced nonsquamous non-small cell lung cancer treatment.

Mixed Results from Phase III TROPION-Lung01 Trial

The MAA submission was based on the Phase III TROPION-Lung01 trial, which yielded mixed results. While the trial demonstrated an improvement in progression-free survival, it failed to significantly enhance overall survival rates. These outcomes led to concerns among investors earlier this year, contributing to the decision to withdraw the application.

Commitment to Further Research and Trials

Despite this setback, AstraZeneca remains committed to exploring the potential of datopotamab deruxtecan in various cancer settings. The company is continuing its ongoing trials to further evaluate the drug's efficacy and safety profile.