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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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The post Daiichi Sankyo and AstraZeneca Report the EC Approval for Datroway to Treat Metastatic Triple Negative Breast Cancer appeared first on PharmaShots.
Daiichi Sankyo and AstraZeneca Report the EC Approval for Datroway to Treat Metastatic Triple Negative Breast Cancer | PharmaVoice