Shots:
- The EMA has validated the Type II Variation MAA for Daiichi‘s Datroway (datopotamab deruxtecan) as monotx. For the 1L treatment of adults with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy; additional regulatory filings are underway
- MAA was supported by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 pts with previously untreated locally recurrent inoperable or metastatic TNBC, regardless of PD-L1 expression, for whom immunotherapy was not an option
- Trial showed Datroway significantly improved OS & PFS vs CT in TNBC pts; data was presented at ESMO 2025
Ref: Daiichi Sankyo| Image: Daiichi Sankyo | Press Release
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