Datopotamab deruxtecan Biologics License Application accepted in the US ...
AstraZeneca and Daiichi Sankyo's BLA for datopotamab deruxtecan (Dato-DXd) was accepted in the US for treating advanced nonsquamous NSCLC post-systemic therapy, based on TROPION-Lung01 Phase III trial results showing improved PFS over docetaxel. FDA decision expected Q4 2024. Ongoing trials aim to establish Dato-DXd as a new standard in NSCLC treatment.
Reference News
Datopotamab deruxtecan Biologics License Application accepted in the US ...
AstraZeneca and Daiichi Sankyo's BLA for datopotamab deruxtecan (Dato-DXd) was accepted in the US for treating advanced nonsquamous NSCLC post-systemic therapy, based on TROPION-Lung01 Phase III trial results showing improved PFS over docetaxel. FDA decision expected Q4 2024. Ongoing trials aim to establish Dato-DXd as a new standard in NSCLC treatment.