Shots:
- The EC has approved Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy; regulatory review is ongoing in China & Japan, as well as Australia, Canada, Singapore & Switzerland as part of Project Orbis
- Approval was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which incl. pts who expressed PD-L1 & who did not express PD-L1
- Trial showed 5mos. improvement in mOS (23.7 vs 18.7mos.) & 43% reduction in disease progression or death risk (mPFS: 10.8 vs 5.6mos.), with 62.5% ORR vs 29.3%; data were published in Annals of Oncology
Ref: Daiichi Sankyo | Image: Daiichi Sankyo & AstraZeneca | Press Release
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