13 January 2025 - Application based on TROPION-Lung05 Phase 2 trial and supported by data from TROPION-Lung01 Phase 3 and TROPION-PanTumor01 Phase 1 trials.
Daiichi Sankyo and AstraZeneca’s biologics license application for datopotamab deruxtecan has been accepted and granted priority review in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer who have received prior systemic therapies, including an EGFR-directed therapy.