Blincyto

Product manufactured by Amgen Inc

Application Nr Approved Date Route Status External Links
BLA125557 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Blincyto Is A Bispecific Cd19-Directed Cd3 T-Cell Engager Indicated For The Treatment Of Adults And Children With: B-Cell Precursor Acute Lymphoblastic Leukemia (All) In First Or Second Complete Remission With Minimal Residual Disease (Mrd) Greater Than Or Equal To 0.1%. This Indication Is Approved Under Accelerated Approval Based On Mrd Response Rate And Hematological Relapse-Free Survival. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In The Confirmatory Trials. ( 1.1 ) Relapsed Or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (All). ( 1.2 ) 1.1 Mrd-Positive B-Cell Precursor All Blincyto Is Indicated For The Treatment Of B-Cell Precursor Acute Lymphoblastic Leukemia (All) In First Or Second Complete Remission With Minimal Residual Disease (Mrd) Greater Than Or Equal To 0.1% In Adults And Children. This Indication Is Approved Under Accelerated Approval Based On Mrd Response Rate And Hematological Relapse-Free Survival. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In The Confirmatory Trials. 1.2 Relapsed Or Refractory B-Cell Precursor All Blincyto Is Indicated For The Treatment Of Relapsed Or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (All) In Adults And Children.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Blinatumomab

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