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 |