Introduction and marketing status of datopotamab

Datopotamab Deruxtecan (Dato-DXd for short, trade name DATROWAY) is an antibody conjugate drug (ADC), developed by Daiichi Sankyo (Daiichi Sankyo) and AstraZeneca (AstraZeneca) jointly developed. The drug mainly targets human epidermal growth factor receptor 2 (TROP2) and can deliver potent topoisomerase I inhibitors to tumor cells, thereby exerting anti-cancer effects. Dedabrotuzumab has shown good anti-tumor activity in clinical trials, especially showing high therapeutic potential in the treatment of triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC).

In terms of marketing, the research and development process of dedabrotuzumab is relatively fast, and marketing applications have been submitted in many countries and regions. In 2024, the U.S. Food and Drug Administration (FDA) granted the drug Breakthrough Therapy Designation and accelerated review for its use in the treatment of patients with TROP2 -positive locally advanced or metastatic non-small cell lung cancer. At the same time, the European Medicines Agency (EMA) is also accelerating its review of the drug’s marketing application to meet the urgent need for new treatments for advanced cancer patients.

In the Chinese market, the launch of dedabrotuzumab is also progressing. Currently, the drug has been included in the priority review process of China's National Medical Products Administration (NMPA), which means it may be approved within the next few years. As China gradually improves its supervision in the field of ADC drugs, dabrotuzumab is expected to become a new option for patients with TROP2 positive tumors. For domestic patients, the introduction of this drug will further enrich the options for targeted therapy and provide new treatment hope for patients with advanced breast cancer and lung cancer.

Although dabrotuzumab has not yet been fully launched globally, multiple clinical trials are validating its efficacy in different cancer types, includingHR+/HER2-breast cancer, small cell lung cancer, etc. If future clinical data continue to support its efficacy and safety, dabrotuzumab is expected to become an important breakthrough drug in the ADC field. At present, patients can pay attention to the approval progress of each country. In some regions, the drug may be available through clinical trials or special drug use channels.

Reference: https://clinicaltrials.gov/