Datopotamab Deruxtecan New BLA Submitted for Accelerated Approval in the U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer

CAR-T Digest - August 2020

Weekly Digest - November 2024

12 Nov 2024: Datopotamab Deruxtecan New BLA Submitted for Accelerated Approval in the U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Daiichi Sankyo and AstraZeneca have submitted a new Biologics License Application (BLA) for accelerated approval of datopotamab deruxtecan (Dato-DXd) to treat EGFR-mutated non-small cell lung cancer (NSCLC) in patients who have received prior systemic therapies
The new BLA is based on the TROPION-Lung05 phase 2 trial, supported by data from TROPION-Lung01 and TROPION-PanTumor01 trials
The companies voluntarily withdrew a previously submitted BLA for nonsquamous NSCLC following feedback from the U.S. FDA
New results from the TROPION-Lung05 and TROPION-Lung01 trials will be presented at the ESMO Asia 2024 Congress, showcasing datopotamab deruxtecan’s potential in EGFR-mutated NSCLC patients
Datopotamab deruxtecan is a TROP2-directed antibody drug conjugate (ADC) jointly developed by Daiichi Sankyo and AstraZeneca, designed to target advanced NSCLC