AstraZeneca, Daiichi Sankyo have voluntarily withdrawn a Dato-DXd MAA in EU

AstraZeneca (AZN) and Daiichi Sankyo (DSNKY) have voluntarily withdrawn the marketing authorization application in the EU for datopotamab deruxtecan for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer based on the TROPION-Lung01 Phase 3 trial, the companies announced. “The decision to withdraw the MAA was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency. 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-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 discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo,” the companies stated.