Blenrep

Product manufactured by Glaxosmithkline Llc

Application Nr Approved Date Route Status External Links
BLA761158 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Blenrep Is Indicated For The Treatment Of Adults With Relapsed Or Refractory Multiple Myeloma Who Have Received At Least 4 Prior Therapies, Including An Anti-Cd38 Monoclonal Antibody, A Proteasome Inhibitor, And An Immunomodulatory Agent. This Indication Is Approved Under Accelerated Approval Based On Response Rate [See Clinical Studies ( 14 )] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial(S). Blenrep Is A B-Cell Maturation Antigen (Bcma)-Directed Antibody And Microtubule Inhibitor Conjugate Indicated For The Treatment Of Adult Patients With Relapsed Or Refractory Multiple Myeloma Who Have Received At Least 4 Prior Therapies Including An Anti-Cd38 Monoclonal Antibody, A Proteasome Inhibitor, And An Immunomodulatory Agent. This Indication Is Approved Under Accelerated Approval Based On Response Rate. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trial(S). ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Belantamab Mafodotin

Comments