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News about "ENHERTU "
US FDA Approves Enhertu for New Early Breast Cancer Indications
Enhertu receives new US approvals for use before and after surgery in HER2-positive breast cancer, supported by positive DESTINY-Breast11 and DESTINY-Breast05 phase 3 trial results.
Enhertu | 18/05/2026 | By News Bureau
Daiichi Sankyo Unveils 5-Year Oncology Growth Strategy
Daiichi Sankyo launches a 5-year strategy targeting global oncology leadership, aiming for 2.3 trillion yen in oncology revenue by 2030 through new indications, breakthrough technologies, and expanded commercialisation capabilities.
Enhertu | 12/05/2026 | By News Bureau
PMDA Expands Use of Enhertu for Second-Line Gastric Cancer in Japan
Regulatory update allows Enhertu to be used earlier in treatment for HER2-positive advanced gastric cancer, backed by phase III data showing improved survival outcomes.
Enhertu | 25/03/2026 | By News Bureau | 225
US Food and Drug Administration grants Priority Review to supplemental application for Enhertu to treat HER2-positive breast cancer patients with residual disease after neoadjuvant therapy, with decision expected in Q3 2026.
Enhertu | 10/03/2026 | By News Bureau | 132
Enhertu Secures US BTD Status in Early HER2-Positive Breast Cancer
The US FDA has granted Breakthrough Therapy Designation to Enhertu for use as post-neoadjuvant treatment in patients with HER2-positive early breast cancer, marking the tenth such designation for AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate, supported by phase III DESTINY-Breast05 trial results.
Enhertu | 23/12/2025 | By News Bureau | 147
Daiichi Sankyo has dosed the first patient in a phase 1 clinical trial of DS3610, its investigational STING agonist Antibody Drug Conjugate (ADC), marking a key step in advancing novel immunotherapy approaches for patients with advanced solid tumours.
ENHERTU | 12/11/2025 | By Dineshwori | 728
US FDA Grants Priority Review for Enhertu + Pertuzumab in HER2+ Metastatic Breast Cancer
The US FDA has granted Priority Review to Enhertu + Pertuzumab for HER2+ metastatic breast cancer, following DESTINY-Breast09 trial results showing a 44 percent reduction in risk of disease progression or death and over three years’ median Progression-Free Survival (PFS), positioning it as a potential new first-line standard of care.
Enhertu | 25/09/2025 | By Dineshwori | 156
CHMP Recommends T-DXd EU Approval in HER2-Low/Ultralow Breast Cancer
ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
ENHERTU | 04/03/2025 | By Aishwarya | 312
Alteogen Signs Exclusive License Deal with Daiichi Sankyo to Develop Subcutaneous ENHERTU
Under the terms of the agreement, Daiichi Sankyo will acquire world-wide rights to use ALT-B4, Alteogen's novel hyaluronidase utilizing Hybrozyme Technology, to develop and commercialize a subcutaneous version of ENHERTU (fam-trastuzumab deruxtecan-nxki).
ENHERTU | 11/11/2024 | By Aishwarya | 502
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