The antibody-drug conjugate datopotamab deruxtecan from Astrazeneca PLC Sponsored ADR (AZN.US) and Daiichi Sankyo Co., Ltd. (DSNKY.US) has been granted FDA priority review qualification.

Astrazeneca PLC Sponsored ADR (AstraZeneca) (AZN.US) and Daiichi Sankyo (DSNKY.US) announced today that the Biologics License Application (BLA) for the antibody-drug conjugate (ADC) datopotamab deruxtecan has been accepted by the US FDA and granted priority review status for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC) who have been previously treated. The FDA is expected to complete the review in the third quarter of 2025. Datopotamab deruxtecan has previously been granted breakthrough therapy designation by the FDA for this patient population. It is worth mentioning that this ADC has been listed as one of the top ten potential blockbuster R&D projects in 2024 by the industry media Evaluate. The BLA is based on data from the phase 2 clinical trial TROPION-Lung05, supported by data from the phase 3 clinical trial TROPION-Lung01. In addition, the BLA is further supported by data from the phase 1 clinical trial TROPION-PanTumor01. A pooled analysis presented at the 2024 European Society for Medical Oncology (ESMO) Asia Congress showed that in the TROPION-Lung05 and TROPION-Lung01 trials, the objective response rate (ORR) for treated patients with locally advanced or metastatic EGFRm NSCLC was 42.7% (95% CI: 33.6%-52.2%), with a median duration of response (DoR) of 7.0 months (95% CI: 4.2-9.8 months). The safety profile of datopotamab deruxtecan remains consistent with previous reports from the TROPION-Lung05 and TROPION-Lung01 trials, with no new safety concerns identified.