Astrazeneca PLC Sponsored ADR (AZN.US) voluntarily withdraws the marketing application for Dato-DXd in non-squamous NSCLC submitted to the European Union.

AstraZeneca PLC Sponsored ADR (AZN.US) and Daiichi Sankyo have voluntarily withdrawn the Marketing Authorization Application (MAA) submitted to the European Union for datopotamab deruxtecan (Dato-DXd, DS-1062) for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in adult patients. The decision to withdraw the MAA was based on feedback from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). Previously, the two companies sought EU approval for the antibody-drug conjugate for the treatment of locally advanced or metastatic non-squamous NSCLC in adults through the MAA. Based on data from March, the MAA was based on the data from the companies' TROPION-Lung01 Phase 3 trial, which met the primary endpoint of progression-free survival but did not achieve the dual primary endpoint of overall survival with statistically significant effect. In November, AstraZeneca PLC Sponsored ADR and Daiichi Sankyo withdrew the marketing application for Dato-DXd in NSCLC in the US, instead seeking FDA accelerated approval for the product in EGFR mutant NSCLC.