The United States Food and Drug Administration has authorized the use of Datroway (datopotamab deruxtecan-dlnk), developed by AstraZeneca (AZN, AZN.L) and Daiichi Sankyo (DSKYF.PK), for adult patients with unresectable or metastatic hormone receptor-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer. This treatment is indicated for patients who have previously undergone endocrine-based therapy and chemotherapy for their unresectable or metastatic conditions.
The decision was supported by findings from the TROPION-Breast01 Phase III trial, which demonstrated a 37% reduction in the risk of disease progression or death compared to standard chemotherapy treatments.
Dave Fredrickson, Executive Vice President of the Oncology Hematology Business Unit at AstraZeneca, stated, "We are proud to bring DATROWAY to individuals battling metastatic HR-positive, HER2-negative breast cancer. This approval signifies the eighth new medication out of the 20 we aim to deliver across AstraZeneca by 2030." Datroway is an intricately designed TROP2-directed antibody-drug conjugate (ADC), discovered by Daiichi Sankyo and co-developed by AstraZeneca and Daiichi Sankyo.
Furthermore, the companies have announced that additional regulatory submissions for DATROWAY in breast cancer treatment are currently under review in the European Union, China, and other international regions.
