Daiichi Sankyo Submits NDA of Datopotamab Deruxtecan to the MHLW for the Treatment of Advanced Breast Cancer
Shots:
- Daiichi Sankyo has reported the NDA submission of datopotamab deruxtecan (Dato-DXd) to the MHLW for treating adults with HR+, HER2 -ve unresectable/recurrent breast cancer
- The NDA was supported by the P-III (TROPION-Breast01) study assessing the safety & efficacy Dato-DXd vs CT (eribulin, capecitabine, vinorelbine or gemcitabine) for treating unresectable/metastatic HR+, HER2 -ve breast cancer patients who have received at least one additional systemic therapy, progressed on & are unsuitable for endocrine therapy
- The results, highlighted at ESMO 2023, depicted improved dual 1EP of PFS & the dual 1EP of OS favoured Dato-DXd but was not significant during the data cut off. Trial continues for OS evaluation
Ref: AstraZeneca | Image: AstraZeneca
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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.