Shots:
- The US FDA 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
- Approval was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which showed 5mos. improvement in mOS & 43% reduction in disease progression or death risk, with 64% ORR vs 30%; data were published in Annals of Oncology
- Application was reviewed under Project Orbis, with review ongoing in Australia, Canada, Singapore & Switzerland. Additional regulatory review is underway in the EU, China & Japan
Ref: AstraZeneca | Image: Daiichi Sankyo & AstraZeneca | Press Release
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