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.
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