(Finance) – AstraZeneca and Daiichi Sankyo have voluntarily withdrew the application for marketing authorization in the EU fordatopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with lung cancer locally advanced or metastatic non-squamous non-small cell (NSCLC), based on the phase III TROPION-Lung01 study.
The decision to withdraw the application was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA), we read in a note. AstraZeneca and Daiichi Sankyo will continue to work to bring datapotamab deruxtecan to lung cancer patients in the EU.
AstraZeneca and Daiichi Sankyo’s application in the EU for datapotamab deruxtecan for the treatment of breast cancer metastatic hormone receptor (HR) positive and HER2 negative, based on the phase III TROPION-Breast01 study, is still under review.