Estimated timetable for global launch of Datopotamab

Datopotamab Deruxtecan (Dato-DXd for short) is a new TROP2-targeted antibody conjugate jointly developed by Daiichi Sankyo and AstraZeneca. 2025At the beginning of 2025, the United States FDA has taken the lead in approving the drug for the treatment of HR-positive, HER2-negative unresectable or metastatic breast cancer that has previously received endocrine therapy and chemotherapy. This is its first official marketing indication. This approval is based on positive data from the pivotal Phase III study of TROPION-Breast01 and marks the official entry of Datopotamab into the global anti-cancer drug market.

In addition to breast cancer indications, the application of dabrotuzumab in the field of non-small cell lung cancer (NSCLC) has also attracted much attention. In June 2025, the U.S. FDA granted it accelerated approval for the treatment of patients with EGFR mutations and who have received targeted drugs and platinum-based chemotherapy. This indication is also listed as a breakthrough therapy, and the FDA gives priority to its review. It is expected that in the third quarter of 2025, the drug will be fully expanded into the field of lung cancer in the United States, further expanding its treatment coverage.

In Europe, 2025At the beginning of 2025, the European Medicines Agency (EMA) has given a positive recommendation for the marketing application of Datopotamab for breast cancer, which is expected to be officially approved by the European Commission in the second half of 2025. In addition, its marketing application for non-small cell lung cancer has also been submitted for review. Overall, Datopotamab is expected to be available by the end of 2025 to 2026It was officially launched in many European countries at the beginning of the year.

In the Asian market, many places, including Japan and China, are actively promoting clinical trials and registration applications. According to public information, Datopotamab's clinical trials in China have entered Phase III and are expected to be completed and a marketing application submitted around 2026. In Japan, since Daiichi Sankyo is a local pharmaceutical company, the review speed may be faster, and it is expected to be launched locally between the end of 2025 and the first half of 2026. Overall, Datopotamab will be launched in major countries and regions around the world in the next 1-2 years, becoming an important new drug in the field of TROP2 target therapy.

Reference materials:https://www.drugs.com/