FDA Accepts AstraZeneca and Daiichi Sankyo’s BLA for Datopotamab Deruxtecan

On 19 February 2024, AstraZeneca and Daiichi Sankyo announced that FDA has accepted its biologics license application (BLA) for the use of datopotamab deruxtecan in treating adult patients with locally advanced or metastatic non–squamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.  FDA has decided the fourth quarter of 2024 as the Prescription Drug User Fee Act date.  The application was approved based on the Phase III results of study TROPION-Lung01 which showed that datopotamab deruxtecan significantly improved progression-free survival (PFS) in comparison to docetaxel (the current standard of care).