Polivy

Product manufactured by Genentech, Inc.

Application Nr Approved Date Route Status External Links
BLA761121 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Polivy In Combination With Bendamustine And A Rituximab Product Is Indicated For The Treatment Of Adult Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma (Dlbcl), Not Otherwise Specified, After At Least Two Prior Therapies. Accelerated Approval Was Granted For This Indication Based On Complete Response Rate [See Clinical Studies (14.1) ] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial. Polivy Is A Cd79b-Directed Antibody-Drug Conjugate Indicated In Combination With Bendamustine And A Rituximab Product For The Treatment Of Adult Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, After At Least Two Prior Therapies. ( 1 ) Accelerated Approval Was Granted For This Indication Based On Complete Response Rate. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Polatuzumab Vedotin

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