AstraZeneca and Daiichi Sankyo Report the US FDA’s Acceptance of BLA for Datopotamab Deruxtecan (Dato-DXd) to Treat Breast Cancer
Shots:
- The BLA was supported by the P-III (TROPION-Breast01) study assessing Dato-DXd vs CT for treating inoperable or metastatic HR+, HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer patients progressing on or ineligible for endocrine therapy & have received one systemic therapy
- The results showed reduction in the disease progression or death risk by 37%, mPFS of 6.9mos. vs 4.9mos., ORR of 36.4% vs 22.9% and a consistent PFS benefit among all subgroups with an ongoing OS evaluation. Results were highlighted at ESMO’23 & SABCS’23
- Another BLA of Dato-DXd supported by the P-III (TROPION-Lung01) study for locally advanced/metastatic NSCLC is under review with the US FDA. Global submissions ongoing for lung & breast cancer
Ref: Daiichi Sankyo | Image: AstraZeneca
Related News:- Daiichi Sankyo Submits NDA of Datopotamab Deruxtecan to the MHLW for the Treatment of Advanced Breast Cancer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
