AstraZeneca withdraws drug approval application in Europe

AstraZeneca surprised with the decision to voluntarily withdraw its application for marketing authorization for an innovative drug for the treatment of a certain type of lung cancer from the European Medicines Agency. The precision medicine drug named datopotamab deruxtecan (Dato-DXd) was developed in close collaboration with the Japanese pharmaceutical company Daiichi Sankyo. Recently, Dato-DXd received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of the type of lung cancer where other therapies fail. The decision to withdraw the application in Europe raises questions about AstraZeneca's future strategy, while the company simultaneously strengthens its presence in the U.S. market. The withdrawal of the application highlights the complex challenges faced by pharmaceutical companies when they aim to establish their innovative therapies globally. The healthcare sector is eagerly observing which steps AstraZeneca will take next.