According to the finance and economics app, on November 13, AstraZeneca (AZN.US) and Daiichi Sankyo announced that based on feedback from the US FDA, the two companies have submitted a Biological License Application (BLA) for the jointly developed Trop2-targeting antibody-drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd), seeking accelerated approval for the therapy to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients with epidermal growth factor receptor (EGFR) mutations who have previously received systemic treatment (including EGFR-targeted therapy). At the same time, both companies voluntarily withdrew the previous BLA submitted to the FDA for treating advanced or metastatic non-squamous NSCLC patients.

It is reported that the new BLA submitted this time is mainly based on the positive results of the TROPION-Lung05 phase 2 clinical trial, supported by data from the TROPION-Lung01 phase 3 and TROPION-PanTumor01 phase 1 clinical trials. The TROPION-Lung05 and TROPION-Lung01 trials assess the efficacy and safety of datopotamab deruxtecan in treated EGFR-mutated NSCLC patients. The combined analysis results of the two trials will be presented at the upcoming European Society for Medical Oncology (ESMO) Asia 2024 Congress.