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• The US FDA has granted BTD to Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2 low or HER2 ultralow breast cancer who have treated with at least 2L endocrine therapy in the metastatic indication or 1L of endocrine therapy if they experienced disease progression within 6mos.
• The designation was based on the 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. 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:- Daiichi Reports the EMA’s Validation of Application for Enhertu to treat HER2 Low or HER2 Ultralow Metastatic Breast Cancer

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