Daiichi Reports the EMA’s Validation of Application for Enhertu to treat HER2 Low or HER2 Ultralow Metastatic Breast Cancer
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- The EMA has validated the Type II variation application of Enhertu as a monothx. for unresectable or metastatic HER2 low or HER2 ultralow breast cancer who have received at least one endocrine therapy in the metastatic indication
- The application is based on P-III (DESTINY-Breast06) study assessing ENHERTU (5.4 mg/kg) vs investigator’s choice of CT (N=866, HER2 low: n=713 for and HER2 ultralow: n=153); significant improvement in 1EP: PFS. Key 2Eps: PFS by BICR, OS in overall population, OS in HER2 low population, and other 2Eps: ORR, DoR, etc.
- This data was presented at ASCO 2024. ENHERTU is jointly developed and commercialized by Daiichi Sankyo and AstraZeneca
Ref: Daiichi Sankyo | Image: Daiichi Sankyo
Related News:- AstraZeneca and Daiichi Sankyo’s Enhertu Receives the NMPA’s Conditional Approval to Treat Gastric Cancer
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