Darzalex

Product manufactured by Janssen Biotech, Inc.

Application Nr Approved Date Route Status External Links
BLA761036 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Darzalex Is Indicated For The Treatment Of Adult Patients With Multiple Myeloma: In Combination With Lenalidomide And Dexamethasone In Newly Diagnosed Patients Who Are Ineligible For Autologous Stem Cell Transplant And In Patients With Relapsed Or Refractory Multiple Myeloma Who Have Received At Least One Prior Therapy. In Combination With Bortezomib, Melphalan And Prednisone In Newly Diagnosed Patients Who Are Ineligible For Autologous Stem Cell Transplant. In Combination With Bortezomib, Thalidomide, And Dexamethasone In Newly Diagnosed Patients Who Are Eligible For Autologous Stem Cell Transplant In Combination With Bortezomib And Dexamethasone In Patients Who Have Received At Least One Prior Therapy. In Combination With Pomalidomide And Dexamethasone In Patients Who Have Received At Least Two Prior Therapies Including Lenalidomide And A Proteasome Inhibitor. As Monotherapy, In Patients Who Have Received At Least Three Prior Lines Of Therapy Including A Proteasome Inhibitor (Pi) And An Immunomodulatory Agent Or Who Are Double-Refractory To A Pi And An Immunomodulatory Agent. Darzalex Is A Cd38-Directed Cytolytic Antibody Indicated For The Treatment Of Adult Patients With Multiple Myeloma: In Combination With Lenalidomide And Dexamethasone In Newly Diagnosed Patients Who Are Ineligible For Autologous Stem Cell Transplant And In Patients With Relapsed Or Refractory Multiple Myeloma Who Have Received At Least One Prior Therapy In Combination With Bortezomib, Melphalan And Prednisone In Newly Diagnosed Patients Who Are Ineligible For Autologous Stem Cell Transplant In Combination With Bortezomib, Thalidomide, And Dexamethasone In Newly Diagnosed Patients Who Are Eligible For Autologous Stem Cell Transplant In Combination With Bortezomib And Dexamethasone In Patients Who Have Received At Least One Prior Therapy In Combination With Pomalidomide And Dexamethasone In Patients Who Have Received At Least Two Prior Therapies Including Lenalidomide And A Proteasome Inhibitor As Monotherapy, In Patients Who Have Received At Least Three Prior Lines Of Therapy Including A Proteasome Inhibitor (Pi) And An Immunomodulatory Agent Or Who Are Double-Refractory To A Pi And An Immunomodulatory Agent. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Daratumumab

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