Shots:
- FDA has accepted sBLA & granted priority review to Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy (PDUFA: Q2’26)
- sBLA 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 29.3% ORR & 7.1mos. DoR
- Application will be reviewed under Project Orbis, with additional regulatory filings for Datroway in breast and lung cancer are ongoing globally
Ref: AstraZeneca | Image: Daiichi Sankyo & AstraZeneca | Press Release
Related News: CSPC Pharmaceutical and AstraZeneca Seal ~$18.5B Long-Acting Peptide Deal for Obesity
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
