Application Nr Approved Date Route Status External Links
BLA761137 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Padcev Tm Is Indicated For The Treatment Of Adult Patients With Locally Advanced Or Metastatic Urothelial Cancer (Muc) Who Have Previously Received A Programmed Death Receptor-1 (Pd-1) Or Programmed Death-Ligand 1 (Pd-L1) Inhibitor, And A Platinum-Containing Chemotherapy In The Neoadjuvant/adjuvant, Locally Advanced Or Metastatic Setting. This Indication Is Approved Under Accelerated Approval Based On Tumor Response Rate [See Clinical Studies ( 14.1 )] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. Padcev Is A Nectin-4-Directed Antibody And Microtubule Inhibitor Conjugate Indicated For The Treatment Of Adult Patients With Locally Advanced Or Metastatic Urothelial Cancer Who Have Previously Received A Programmed Death Receptor-1 (Pd-1) Or Programmed Death-Ligand 1 (Pd-L1) Inhibitor, And A Platinum-Containing Chemotherapy In The Neoadjuvant/adjuvant, Locally Advanced Or Metastatic Setting. ( 1 ) This Indication Is Approved Under Accelerated Approval Based On Tumor Response Rate. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. ( 14.1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Enfortumab Vedotin

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