The decision to withdraw the Marketing Authorization Application (MAA) for datopotamab deruxtecan was based on feedback from the European Medicines Agency (EMA). AstraZeneca and Daiichi Sankyo remain committed to bringing this treatment to lung cancer patients in the EU through a robust clinical development program, which includes seven key trials in various lung cancer settings.
The application for datopotamab deruxtecan, targeting hormone receptor-positive, HER2-negative metastatic breast cancer, based on the TROPION-Breast01 Phase III trial, is still under review in the EU. This TROP2-directed DXd antibody-drug conjugate (ADC) was discovered by Daiichi Sankyo and co-developed with AstraZeneca.
At the 2024 WCLC, AstraZeneca presented findings from the TROPION-Lung01 study, which involved 299 and 305 patients in two treatment groups. The median progression-free survival (PFS) was 4.4 months for the Dato-DXd group compared to 3.7 months for the docetaxel group. The median overall survival (OS) was 12.9 months versus 11.8 months, not reaching statistical significance.
