AstraZeneca, Daiichi Sankyo voluntarily withdraws datopotamab deruxtecan application in EU for lung cancer

The decision to withdraw the MAA was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). AstraZeneca and Daiichi Sankyo will continue to work to bring datopotamab deruxtecan to patients with lung cancer in the EU who can benefit and are committed to unlocking the potential of this medicine in lung cancer through our robust clinical development programme which includes seven pivotal trials in various lung cancer settings.

AstraZeneca and Daiichi Sankyo’s application in the EU for datopotamab deruxtecan for the treatment of hormone receptor (HR)-positive, HER2-negative metastatic breast cancer based on the TROPION-Breast01 Phase III trial remains under review.

Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.

Nearly 2.5 million lung cancer cases were diagnosed globally in 2022. In Europe, nearly half a million lung cancer cases were diagnosed in 2022. Lung cancer is broadly split into small or non-small cell lung cancer, the latter accounting for about 80% of cases. While immunotherapy and targeted therapies have improved outcomes in the 1st-line setting, most patients eventually experience disease progression and receive chemotherapy. For decades, chemotherapy has been the last treatment available for patients with advanced NSCLC, despite limited effectiveness and known side effects.

TROP2 is a protein broadly expressed in the majority of NSCLC tumours. There is currently no TROP2-directed ADC approved for the treatment of lung cancer.

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