AstraZeneca Withdraws EU Application for Lung Cancer Drug Dato-DXd

AstraZeneca and Daiichi Sankyo have withdrawn their EU marketing application for the lung cancer drug datopotamab deruxtecan following feedback from the European Medicines Agency.

AstraZeneca PLC, in collaboration with Daiichi Sankyo Co., has decided to withdraw its marketing authorization application for the lung cancer drug datopotamab deruxtecan (Dato-DXd) in the European Union. This decision follows feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). The drug, aimed at treating advanced nonsquamous non-small cell lung cancer (NSCLC), was under review based on the TROPION-Lung01 Phase III trial results. Despite the withdrawal, AstraZeneca and Daiichi Sankyo remain committed to advancing Dato-DXd through ongoing clinical trials and exploring its potential in various lung cancer settings. The companies have emphasized their dedication to bringing this treatment to patients who could benefit from it in the EU. The withdrawal highlights the challenges faced in bringing new cancer therapies to market, particularly in the competitive and complex field of oncology. AstraZeneca's application for Dato-DXd for hormone receptor-positive, HER2-negative metastatic breast cancer remains under review in the EU. The decision to withdraw the application has sparked discussions about the future of NSCLC treatment options and AstraZeneca's strategic direction in the European market. The pharmaceutical giant continues to focus on its robust clinical development program, which includes multiple pivotal trials across different cancer settings. AstraZeneca's shares showed little change following the announcement, reflecting the market's cautious optimism about the company's ongoing efforts in oncology.

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