Daiichi Sankyo and AstraZeneca Reports the US FDA’s Acceptance of BLA for Datopotamab Deruxtecan (Dato-DXd) to Treat Non-Small Cell Lung Cancer
Shots:
- The BLA was based on the results of P-III (TROPION-Lung01) study assessing the safety & efficacy of Dato-DXd vs docetaxel for treating locally advanced/metastatic NSCLC patients previously treated with a systemic therapy
- In the study, Dato-DXd improved the dual 1EP of PFS, OS was favorable but insignificant at the time of data cut off in the overall population while in non-squamous NSCLC patients, favorable PFS & OS trend was found. The study is in progress for further OS evaluation
- Additionally, BLA for Dato-DXd supported by data from the P-III (TROPION-Breast01) study is anticipated for US FDA’s acceptance to treat metastatic HR+, HER2-negative breast cancer. Global submissions in lung and breast cancer are in progress
Ref: Daiichi Sankyo| Image: Daiichi Sankyo
Related News:- Daiichi Sankyo and AstraZeneca Report P-III Trial (TROPION-Breast01) Results of Datopotamab Deruxtecan for Breast Cancer
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
