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Results For "trastuzumab-deruxtecan"

22 News Found

AstraZeneca Pharma India receives permission for sale and distribution of Trastuzumab deruxtecan
News | May 04, 2023

AstraZeneca Pharma India receives permission for sale and distribution of Trastuzumab deruxtecan

The receipt of this permission paves way for the launch of Trastuzumab deruxtecan (Enhertu) solution of 100mg/5mL in India


Trastuzumab deruxtecan type II variation application validated by EMA
Biotech | December 28, 2021

Trastuzumab deruxtecan type II variation application validated by EMA

Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1)


Trastuzumab Deruxtecan supplemental New Drug Application for breast cancer submitted in Japan
Biotech | December 14, 2021

Trastuzumab Deruxtecan supplemental New Drug Application for breast cancer submitted in Japan

In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020


AstraZeneca, Daiichi Sankyo announce Enhertu plus pertuzumab demonstrated clinically meaningful improvement as 1st-line therapy for patients with metastatic breast cancer
News | April 22, 2025

AstraZeneca, Daiichi Sankyo announce Enhertu plus pertuzumab demonstrated clinically meaningful improvement as 1st-line therapy for patients with metastatic breast cancer

DESTINY-Breast09 Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic patient population versus current 1st-line standard of care


Enhertu approved in EU in post-ET breast cancer
Drug Approval | April 04, 2025

Enhertu approved in EU in post-ET breast cancer

Approval brings AstraZeneca and Daiichi Sankyo’s Enhertu earlier in the treatment of HR-positive, HER2-low breast cancer and broadens the eligible patient population to those with HER2-ultralow disease


Enhertu approved in US for breast cancer post more endocrine therapies
News | January 30, 2025

Enhertu approved in US for breast cancer post more endocrine therapies

Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year


Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
Drug Approval | October 16, 2024

Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC

Enhertu demonstrated clinically meaningful efficacy in previously treated patients


Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer
Drug Approval | August 13, 2024

Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer

Third approval in China for AstraZeneca and Daiichi Sankyo’s Enhertu in less than two years


Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer
Diagnostic Center | April 11, 2024

Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer

Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2


Enhertu approved in the US as first tumour-agnostic HER2-directed therapy
Drug Approval | April 06, 2024

Enhertu approved in the US as first tumour-agnostic HER2-directed therapy

Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers