India Pharma Outlook Team | Wednesday, 15 January 2025
The Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) from AstraZeneca and Daiichi Sankyo has been accepted and awarded Priority Review status in the US for treating adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who have undergone prior systemic treatments, including an EGFR-targeted therapy.
The Food and Drug Administration (FDA) provides Priority Review status to drug applications that, upon approval, would present substantial advancements over current treatments by showing enhanced safety or effectiveness, averting serious health issues, or improving patient adherence. The date for the Prescription Drug User Fee Act, which is the FDA's scheduled action date for its regulatory decision, is expected in the third quarter of 2025. The FDA previously awarded Breakthrough Therapy Designation (BTD) to datopotamab deruxtecan for this group of patients.
The BLA and BTD are founded on information from the TROPION-Lung05 phase II trial and are reinforced by data from the TROPION-Lung01 Phase III trial. Furthermore, the BLA is backed by findings from the TROPION-PanTumor01 phase I clinical study.
In a pooled analysis involving patients with previously treated advanced or metastatic EGFRm NSCLC from the TROPION-Lung05 and TROPION-Lung01 trials presented at the European Society for Medical Oncology (ESMO) Asia 2024 Congress, datopotamab deruxtecan exhibited a confirmed objective response rate (ORR) of 42.7% (95% confidence interval [CI] 33.6-52.2), as evaluated by blinded independent central review (BICR), and a median duration of response (DoR) of 7.0 months (95% CI 4.2-9.8).
, CDSCO.jpg)
