EMA grants dual validation for Daiichi Sankyo and AstraZeneca’s Cancer ADC

CAR-T Digest - August 2020

04 Mar 2024: EMA grants dual validation for Daiichi Sankyo and AstraZeneca’s Cancer ADC

The European Medicines Agency (EMA) has validated the jointly developed TROP2-directed therapy, Dato-DXd, for patients with breast or lung cancer, based on positive Phase III data
Two marketing authorization applications for Dato-DXd have been approved by the EMA, targeting locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) and unresectable or metastatic hormone receptor (HR) positive, HER2-negative breast cancer
The submission for NSCLC treatment was supported by the Phase III TROPION-Lung01 trial, comparing Dato-DXd to docetaxel chemotherapy, while the submission for breast cancer treatment was based on the Phase III TROPION-Breast01 trial
Results from both trials demonstrated significant improvements in progression-free survival with Dato-DXd compared to chemotherapy in their respective cancer types
Additionally, the US FDA has accepted Dato-DXd’s filing for review for NSCLC treatment, with a decision expected later in the year, and a biologics license application has been submitted to the FDA for breast cancer treatment