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Results For "Enhertu"

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Japan approves ENHERTU for treatment of adult patients with HER2 positive unresectable breast cancer
Drug Approval | November 27, 2022

Japan approves ENHERTU for treatment of adult patients with HER2 positive unresectable breast cancer

Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial


ENHERTU delays disease progression in DESTINYBreast02 Phase 3 Trial
Diagnostic Center | August 15, 2022

ENHERTU delays disease progression in DESTINYBreast02 Phase 3 Trial

Results consistent with previous trials, reinforcing benefit of Daiichi Sankyo and AstraZeneca’s ENHERTU in previously treated patients


Enhertu approved in the US as the first HER2-directed therapy for patients with previously treated HER2-mutant metastatic non-small cell lung cancer
News | August 13, 2022

Enhertu approved in the US as the first HER2-directed therapy for patients with previously treated HER2-mutant metastatic non-small cell lung cancer

Based on DESTINY-Lung02 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu reported a confirmed objective response rate of 57.7% in patients with HER2-mutant disease


ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer
Drug Approval | August 09, 2022

ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer

Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy


Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer
Biotech | April 27, 2022

Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer

Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers


Enhertu Phase III results to redefine how metastatic breast cancer is classifed
Biotech | February 21, 2022

Enhertu Phase III results to redefine how metastatic breast cancer is classifed

Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.


Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer
Drug Approval | February 01, 2025

Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer

The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.


AstraZeneca advances ambition to improve standards of care in multiple cancer types
News | September 04, 2024

AstraZeneca advances ambition to improve standards of care in multiple cancer types

Presidential Symposium for NIAGARA will highlight practice-changing impact of a perioperative Imfinzi-based regimen in bladder cancer


AstraZeneca furthers ambition to transform outcomes in early lung cancer at ASCO 2024
News | May 27, 2024

AstraZeneca furthers ambition to transform outcomes in early lung cancer at ASCO 2024

Back-to-back plenary presentations for LAURA and ADRIATIC Phase III trials reinforce the potential of Tagrisso and Imfinzi in early lung cancer settings