AstraZeneca and Daiichi Sankyo’s Antibody-Drug Conjugate Datopotamab Deruxtecan Receives FDA Priority Review for EGFR-Mutated NSCLC

According to the Zhicheng Finance APP, AstraZeneca (AstraZeneca) (AZN.US) and Daiichi Sankyo (Daiichi Sankyo) (DSNKY.US) announced today,The Biologics License Application (BLA) for the antibody-drug conjugate (ADC) datopotamab deruxtecan has been accepted by the U.S. FDA and granted Priority Review.For the treatment of adult patients with previously treated locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The FDA is expected to complete its review in the third quarter of 2025.For this patient population, datopotamab deruxtecan has previously been granted Breakthrough Therapy Designation by the FDA.It is worth mentioning that this ADC was listed by the industry media Evaluate as one of the top ten potential blockbuster R&D projects in 2024.

This BLA is based on data from the Phase 2 clinical trial TROPION-Lung05, supported by data from the Phase 3 clinical trial TROPION-Lung01. Additionally, the BLA is backed by data from the Phase 1 clinical trial TROPION-PanTumor01.

In a pooled analysis presented at the 2024 European Society for Medical Oncology (ESMO) Asia Congress, data from patients with locally advanced or metastatic EGFR-mutated NSCLC who were treated in the TROPION-Lung05 and TROPION-Lung01 trials showed that datopotamab deruxtecan had an objective response rate (ORR) of 42.7% (95% CI: 33.6%-52.2%) and 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 previous reports from the TROPION-Lung05 and TROPION-Lung01 trials, with no new safety concerns identified.