AstraZeneca, Daiichi Sankyo Withdraw EU MAA for Dato-DXd

AstraZeneca and Daiichi Sankyo have voluntarily withdrawn their marketing authorisation application (MAA) for datopotamab deruxtecan (Dato-DXd) in the European Union (EU) for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). The decision was based on feedback from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), which indicated that the data from the TROPION-Lung01 Phase III trial did not demonstrate a significant overall survival (OS) benefit for Dato-DXd compared to docetaxel in this indication.

The TROPION-Lung01 trial, which enrolled approximately 600 patients, showed improved progression-free survival (PFS) with Dato-DXd compared to docetaxel. However, the OS data did not demonstrate a significant difference between the two treatments. In the intention-to-treat (ITT) population, the median OS was 12.9 months for Dato-DXd vs 11.8 months for docetaxel (HR, 0.94; 95% CI, 0.78-1.14; P = 0.530). In the nonsquamous NSCLC subgroup, the median OS was 14.6 months for Dato-DXd vs 12.3 months for docetaxel (HR, 0.84; 95% CI, 0.68-1.05).

The withdrawal of the MAA for Dato-DXd in the EU has implications for the ongoing clinical development programme of the drug in lung cancer. AstraZeneca and Daiichi Sankyo remain committed to unlocking the potential of Dato-DXd in lung cancer through their robust clinical development programme, which includes seven pivotal trials in various lung cancer settings. However, investors should monitor the progress of these trials and any regulatory updates to assess the potential impact on the drug's future approval and market access.

The withdrawal of the MAA for Dato-DXd in the EU may also impact the timeline and scope of future clinical trials for the drug in lung cancer settings. The decision was based on feedback from the CHMP, suggesting potential concerns about the drug's efficacy or safety profile. This setback could delay the drug's approval in the EU, pushing back the timeline for patients to access it. However, the companies remain committed to continuing their clinical development programme, potentially expanding its scope to other lung cancer indications or patient populations.



In conclusion, AstraZeneca and Daiichi Sankyo's withdrawal of the MAA for Dato-DXd in the EU highlights the importance of regulatory feedback and the need for further investigation or refinement of a drug's application. While this setback may delay the drug's approval in the EU, the companies remain committed to unlocking the potential of Dato-DXd in lung cancer through their ongoing clinical development programme. Investors should closely monitor the progress of these trials and any regulatory updates to assess the potential impact on the drug's future approval and market access.