AstraZeneca's (AZN.US) and Daiichi Sankyo's (DSNKY.US) antibody-drug conjugate datopotamab deruxtecan has been granted FDA priority review status.

AstraZeneca (AZN.US) and Daiichi Sankyo (DSNKY.US) today announced that the FDA has accepted for filing and granted priority review to their Biologics License Application (BLA) for datopotamab deruxtecan, an antibody-drug conjugate (ADC), for the treatment of adult patients with EGFRm non-small cell lung cancer (NSCLC) who have received prior systemic therapy. The FDA expects to complete its review in the third quarter of 2025. Datopotamab deruxtecan previously received a Breakthrough Therapy Designation for this patient population. Notably, the ADC was ranked by industry media Evaluate as one of the top 10 potential blockbuster development projects in 2024. The BLA was based on data from the Phase 2 TROPION-Lung05 trial and supported by data from the Phase 3 TROPION-Lung01 trial. In addition, the BLA was supported by data from the Phase 1 TROPION-PanTumor01 trial. An integrated analysis presented at the 2024 European Society for Medical Oncology (ESMO) Asia Summit showed that datopotamab deruxtecan achieved an objective response rate (ORR) of 42.7% (95% CI: 33.6%-52.2%) in patients with locally advanced or metastatic EGFRm NSCLC who had received prior systemic therapy in the TROPION-Lung05 and TROPION-Lung01 trials, with a median duration of response (DoR) of 7.0 months (95% CI: 4.2-9.8 months). The safety profile of datopotamab deruxtecan was consistent with previously reported data from the TROPION-Lung05 and TROPION-Lung01 trials, with no new safety issues identified.