AstraZeneca Plc and Daiichi Sankyo have opted to voluntarily retract their application for marketing authorization within the European Union for datopotamab deruxtecan (Dato-DXd), intended for adult patients suffering from locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). This decision follows insights provided by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Despite the withdrawal, both companies affirm their unwavering commitment to providing access to datopotamab deruxtecan for European lung cancer patients who stand to gain from its benefits. They are actively pursuing the potential of this medicine through a comprehensive clinical development program that includes seven significant trials across diverse settings for lung cancer.
In parallel, AstraZeneca and Daiichi Sankyo continue to seek approval for datopotamab deruxtecan in the EU for the treatment of hormone receptor-positive, HER2-negative metastatic breast cancer. This is based on the ongoing review of data from the TROPION-Breast01 Phase III trial.
Datopotamab deruxtecan is an innovatively engineered TROP2-directed DXd antibody drug conjugate (ADC), originally developed by Daiichi Sankyo, now being collaboratively developed alongside AstraZeneca.
