Datopotamab deruxtecan’s BLA accepted in the US for advanced NSCLC in previously treated patients

CAR-T Digest - August 2020

19 Feb 2024: Datopotamab deruxtecan’s BLA accepted in the US for advanced NSCLC in previously treated patients

Datopotamab Deruxtecan is a TROP2-directed DXd antibody-drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo
BLA is based on results from the pivotal TROPION-Lung01 Phase III trial in which Datopotamab Deruxtecan demonstrated a statistically significant improvement in PFS compared to docetaxel, the current standard of care, in IL+ setting.
If approved, Datopotamab Deruxtecan may be the first TROP2-directed antibody-drug conjugate for patients with lung cancer
The FDA’s PDUFA date falls in the fourth quarter of 2024
Additional regulatory submissions for Datopotamab Deruxtecan in lung and breast cancer are underway globally. A parallel BLA based on results from the pivotal TROPION-Breast01 Phase III trial is pending acceptance in the US for metastatic HR+, HER2-negative breast cancer