AstraZeneca PLC Sponsored ADR (AZN.US) submits potential blockbuster ADC therapy for FDA approval.

On November 13, Astrazeneca PLC Sponsored ADR(AZN.US) and Daiichi Sankyo announced that, based on feedback from the US FDA, the two companies have submitted a Biologics License Application (BLA) for their 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, the two companies voluntarily withdrew the previously submitted BLA to the FDA for the treatment of advanced or metastatic non-squamous NSCLC patients. It is reported that the new BLA submission 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 evaluated the efficacy and safety of datopotamab deruxtecan in patients with treated EGFR mutant NSCLC. The combined analysis results of the two trials will be presented at the upcoming European Society for Medical Oncology (ESMO) Asia 2024 Conference.