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.
Daiichi Sankyo | 23/12/2025 | By News Bureau
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.
Daiichi Sankyo | 12/11/2025 | By Dineshwori | 294
Daiichi Sankyo Files sNDA in Japan for ENHERTU Plus Pertuzumab in HER2-Positive Breast Cancer
Daiichi Sankyo has filed a supplemental NDA in Japan for ENHERTU plus Pertuzumab in HER2-positive breast cancer. If approved, this therapy could enter the first-line metastatic setting and has the potential to become a new standard of care.
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Daiichi Sankyo | 08/10/2025 | By Dineshwori | 456
Daiichi Sankyo Establishes Third Research Institute in San Diego
Daiichi Sankyo Research Institutes, located in Boston, Munich and San Diego, are advancing the vision of Daiichi Sankyo to foster the development of next-generation medicines.
Daiichi Sankyo | 04/10/2025 | By Dineshwori | 103
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.
Daiichi Sankyo | 25/09/2025 | By Dineshwori
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.
Daiichi Sankyo | 04/03/2025 | By Aishwarya | 218
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).
Daiichi Sankyo | 11/11/2024 | By Aishwarya | 405
Daiichi Sankyo's quizartinib plus chemotherapy improves OS in patients with AML
Quizartinib combined with standard induction and consolidation chemotherapy and then continued as a single agent demonstrated a 22.4 per cent reduction in the risk of death
Daiichi Sankyo | 13/06/2022 | By Sudeep Soparkar | 836
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