Enhertu

Product manufactured by Daiichi Sankyo Inc.

Application Nr Approved Date Route Status External Links
BLA761139 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Enhertu Is Indicated For The Treatment Of Adult Patients With Unresectable Or Metastatic Her2-Positive Breast Cancer Who Have Received Two Or More Prior Anti-Her2-Based Regimens In The Metastatic Setting. This Indication Is Approved Under Accelerated Approval Based On Tumor Response Rate And Duration Of Response [See Clinical Studies (14.1) ] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial. Enhertu Is A Her2-Directed Antibody And Topoisomerase Inhibitor Conjugate Indicated For The Treatment Of Adult Patients With Unresectable Or Metastatic Her2-Positive Breast Cancer Who Have Received Two Or More Prior Anti-Her2-Based Regimens In The Metastatic Setting. ( 1 ) This Indication Is Approved Under Accelerated Approval Based On Tumor Response Rate And Duration Of Response. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial. ( 1 , 14.1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Trastuzumab Deruxtecan

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