Datopotamab Deruxtecan Application in the EU for Patients with Advanced non-sqNSCLC Voluntarily Withdrawn
“Daiichi Sankyo and AstraZeneca have voluntarily withdrawn the marketing authorization application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) based on the TROPION-Lung01 phase 3 trial. The decision to withdraw the MAA was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA).”
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