The FDA has granted priority review to the supplemental biologics license application for Datroway (datopotamab deruxtecan) in adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.
The application is supported by results from the global phase 3 TROPION-Breast02 trial, which enrolled 644 patients and showed Datroway reduced the risk of disease progression or death by 43% and improved median overall survival by five months compared to chemotherapy. Datroway also showed an objective response rate of 62.5% and a duration of response of 12.3 months, compared to 29.3% and 7.1 months with chemotherapy, according to a Feb. 3 company news release.
The FDA is expected to make a decision in the second quarter of 2026.
At the Becker's Perioperative Summit, taking place September 14–15 in Chicago, perioperative leaders and healthcare executives will focus on improving operating room efficiency, enhancing patient safety, optimizing staffing and driving innovation across surgical services. Apply for complimentary registration now.
