AstraZeneca & Daiichi Sankyo Report the EMA’s Validation of two MAAs for Datopotamab Deruxtecan (Dato-DXd) to Treat NSCLC and Breast Cancer
Shots:
- The EMA has validated two MAAs of Dato-DXd to treat locally advanced/metastatic non-squamous NSCLC patients requiring systemic therapy after prior treatment & unresectable/metastatic HR+, HER2-negative breast cancer who have received at least one additional systemic therapy, progressed on and are unsuitable for endocrine therapy. Further global (incl. the US) regulatory submissions for the same are ongoing
- The applications were based on two P-III (TROPION-Lung01 & TROPION-Breast01) studies determining the safety & efficacy of Dato-DXd vs docetaxel to treat NSCLC & Dato-DXd vs CT to treat breast cancer, respectively
- The studies revealed improvement in PFS with Dato-DXd vs CT in both types of cancers
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.
