DS-8201

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

April 17, 2019

AstraZeneca Teams with Daiichi Sankyo to Speed Development of HER2-positive Advanced Breast Cancer Therapy

News

AstraZeneca is starting a collaboration with Daiichi Sankyo for the global production and commercialization of trastuzumab deruxtecan (DS-8201), a novel antibody-drug conjugate under clinical studies for the treatment of advanced HER2-positive ... Read more