News about "Daiichi Sankyo"

Daiichi Sankyo Submits sNDA in Japan for Datroway in First-Line Metastatic TNBC

Daiichi Sankyo files supplemental application in Japan for Datroway as a first-line treatment for metastatic triple negative breast cancer based on phase III trial data.

Daiichi Sankyo | 13/02/2026 | By News Bureau

AstraZeneca and Daiichi Sankyo's Datroway Receives FDA Priority Review for First-Line Metastatic TNBC Treatment

The FDA has granted Priority Review to Datroway for first-line treatment of metastatic triple-negative breast cancer patients ineligible for immunotherapy, with a regulatory decision expected in Q2 2026.

Daiichi Sankyo | 04/02/2026 | By News Bureau

EU Validates ENHERTU Plus Pertuzumab for First-Line HER2-Positive Metastatic Breast Cancer

The European Union (EU) has validated the first-line use of ENHERTU in combination with pertuzumab for patients with HER2-positive metastatic breast cancer, following results from the DESTINY-Breast09 phase-III trial, which demonstrated a significant improvement in Progression-Free Survival (PFS) compared to current standard treatments.

Daiichi Sankyo | 20/01/2026 | By News Bureau |  128

First Patient Dosed in Phase III Tropian-Lung17 Trial of Datroway in Advanced NSCLC

The global Phase III study evaluates Datroway versus docetaxel in Trop2 NMR-positive advanced nonsquamous NSCLC patients previously treated with immunotherapy and platinum chemotherapy.

Daiichi Sankyo | 14/01/2026 | By News Bureau |  107

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 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.

Daiichi Sankyo | 12/11/2025 | By Dineshwori |  451

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 |  479

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 |  116

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 |  111

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 |  248