Datopotamab deruxtecan application in the EU for patients with advanced nonsquamous non-small cell lung cancer voluntarily withdrawn

CAR-T Digest - August 2020

24 Dec 2024: Datopotamab deruxtecan application in the EU for patients with advanced nonsquamous non-small cell lung cancer voluntarily withdrawn

AstraZeneca and Daiichi Sankyo have voluntarily withdrawn their marketing authorization application (MAA) for datopotamab deruxtecan (Dato-DXd) for treating adult patients with locally advanced or metastatic non-squamous NSCLC in the EU, following feedback from the European Medicines Agency (EMA)
Despite the MAA withdrawal, the companies are committed to advancing datopotamab deruxtecan for lung cancer patients in the EU through a robust clinical development program, including seven pivotal Phase III trials in various lung cancer settings
The MAA for datopotamab deruxtecan for the treatment of hormone receptor-positive, HER2-negative metastatic breast cancer remains under review in the EU, based on data from the TROPION-Breast01 Phase III trial
The U.S. FDA has granted Breakthrough Therapy Designation to datopotamab deruxtecan for treating adult patients with locally advanced or metastatic EGFR-mutated NSCLC, and a Biologics License Application has been submitted for this indication