AstraZeneca's (AZN.US) potential blockbuster ADC therapy submits an NDA to FDA

On November 13, AstraZeneca (AZN.US) and Daiichi Sankyo announced that they had submitted a biologics license application (BLA) to the U.S. FDA for datopotamab deruxtecan (Dato-DXd), a Trop2-targeting antibody-drug conjugate (ADC) jointly developed by the two companies, seeking accelerated approval for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations who have received systemic therapy, including EGFR-targeted therapy. At the same time, the two companies voluntarily withdrew the BLA previously submitted to the FDA for the treatment of advanced or metastatic non-squamous NSCLC.

It is known that the new BLA was mainly based on the positive results of the TROPION-Lung05 clinical 2nd phase trial and supported by the data of the TROPION-Lung01 clinical 3rd phase and TROPION-PanTumor01 clinical 1st phase trials. The TROPION-Lung05 and TROPION-Lung01 trials evaluated the efficacy and safety of datopotamab deruxtecan in EGFR-mutated NSCLC patients who had received prior systemic therapy. The combined analysis results of the two trials will be presented at the 2024 European Society for Medical Oncology (ESMO) Asia conference.