News about "ENHERTU "

Enhertu Plus Pertuzumab Approved in China for First-Line HER2-Positive Metastatic Breast Cancer

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 101

EMA Committee Recommends Approval of AstraZeneca and Daiichi Sankyo's Enhertu Plus Pertuzumab

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

US FDA Approves Enhertu for New Early Breast Cancer Indications

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 160

Daiichi Sankyo Unveils 5-Year Oncology Growth Strategy

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 241

PMDA Expands Use of Enhertu for Second-Line Gastric Cancer in Japan

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 350

AstraZeneca and Daiichi Sankyo Secure US Food and Drug Administration Priority Review for Enhertu in HER2-Positive Breast Cancer

AstraZeneca and Daiichi Sankyo Secure US Food and Drug Administration Priority Review for Enhertu in HER2-Positive Breast Cancer

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 163

Enhertu Secures US BTD Status in Early HER2-Positive Breast Cancer

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 177

Daiichi Sankyo Initiates First-in-Human Trial for DS3610, a First-in-Class STING Agonist ADC for Advanced Solid Tumours

Daiichi Sankyo Initiates First-in-Human Trial for DS3610, a First-in-Class STING Agonist ADC for Advanced Solid Tumours

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 954

US FDA Grants Priority Review for Enhertu + Pertuzumab in HER2+ Metastatic Breast Cancer

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 210

CHMP Recommends T-DXd EU Approval in HER2-Low/Ultralow Breast Cancer

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 351


 

 

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