Dato-DXd new BLA submitted, NSQ BLA withdrawn
12 November 2024 Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer AstraZeneca and Daiichi Sankyo's new application is based on the TROPION-Lung05 Phase II trial and supported by data from additional trials including TROPION-Lung01 Previously submitted BLA based on TROPION-Lung01 Phase III trial for patients with nonsquamous NSCLC has been voluntarily withdrawn AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated