DESTINY-Breast01 Phase 2 trial

February 22, 2021August 24, 2022

Enhertu Approved in UK for Inoperable, Advanced Breast Cancer

News

Enhertu (trastuzumab deruxtecan) has been granted conditional approval in the U.K. for the treatment of adults with inoperable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based ... Read more

January 25, 2021January 25, 2021

Enhertu Approved in EU for Inoperable, Advanced Breast Cancer

News

The European Commission has conditionally approved Enhertu (trastuzumab deruxtecan) for adults in the EU with inoperable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens. ... Read more

July 9, 2020July 9, 2020

EMA Grants Trastuzumab Deruxtecan Accelerated Assessment for Advanced HER2-positive Breast Cancer

News

The European Medicines Agency (EMA) has validated Daiichi Sanyoko‘s marketing authorization application for trastuzumab deruxtecan (DS-8201) for the treatment of inoperable or metastatic HER2-positive breast cancer, the company announced. The ... Read more

January 2, 2020January 3, 2020

Enhertu Gets FDA Approval for Treatment of Advanced HER2-positive Breast Cancer

News

The U.S. Food and Drug Administration (FDA) approved Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with inoperable or metastatic HER2-positive breast cancer who have received at least two prior ... Read more

October 23, 2019October 24, 2019

Daiichi Sankyo Files New Drug Application for DS-8201 in Japan

News

Daiichi Sankyo has submitted an application to Japanese regulatory authorities asking that its investigational therapy trastuzumab deruxtecan (DS-8201) be approved as a treatment for people with HER2-positive metastatic breast cancer. ... Read more

May 15, 2019

Experimental Antibody Therapy Leads to Significant Responses in HER2-positive Breast Cancer, Phase 2 Trial Shows

News

Trastuzumab deruxtecan (DS-8201), an investigational antibody-drug conjugate developed by AstraZeneca with Daiicho Sankyo, led to clinically meaningful responses in patients with advanced HER2-positive breast cancer, a Phase 2 clinical trial ... Read more