Japan Approves Enhertu and Datroway for New First-Line Metastatic Breast Cancer Indications
Japan has approved new first-line metastatic breast cancer indications for Daiichi Sankyo’s Enhertu and Datroway, expanding treatment options for patients with HER2-positive and triple-negative breast cancer.
Enhertu | 17/09/2026 | By News Bureau | 417
The European Union (EU) has approved Enhertu plus pertuzumab as a new first-line regimen for HER2-positive metastatic breast cancer, reducing progression or death risk by 44 percent.
Enhertu | 02/09/2026 | By News Bureau
Enhertu Plus Pertuzumab Approved in China for First-Line HER2-Positive Metastatic Breast Cancer
Enhertu plus pertuzumab has been approved in China as first-line treatment for HER2-positive metastatic breast cancer, based on positive phase 3 results.
Enhertu | 13/08/2026 | By News Bureau | 139
EMA Committee Recommends Approval of AstraZeneca and Daiichi Sankyo's Enhertu Plus Pertuzumab
If approved, AstraZeneca and Daiichi Sankyo’s Enhertu plus pertuzumab would become first new treatment in the European Union (EU) in more than a decade for first-line HER2-positive metastatic breast cancer.
Enhertu | 25/07/2026 | By News Bureau | 108
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 | 202
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 | 304
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 | 399
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 | 200
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 | 195
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 | 1085
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