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1 Indications And Usage Imfinzi Is A Programmed Death-Ligand 1 (Pd-L1) Blocking Antibody Indicated: • For The Treatment Of Adult Patients With Locally Advanced Or Metastatic Urothelial Carcinoma Who: • Have Disease Progression During Or Following Platinum-Containing Chemotherapy. ( 1.1 ) • Have Disease Progression Within 12 Months Of Neoadjuvant Or Adjuvant Treatment With Platinum-Containing Chemotherapy. ( 1.1 ) This Indication Is Approved Under Accelerated Approval Based On Tumor Response Rate And Duration Of Response. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. ( 1.1 ) • For The Treatment Of Adult Patients With Unresectable, Stage Iii Non-Small Cell Lung Cancer (Nsclc) Whose Disease Has Not Progressed Following Concurrent Platinum-Based Chemotherapy And Radiation Therapy. ( 1.2 ) • In Combination With Etoposide And Either Carboplatin Or Cisplatin, As First-Line Treatment Of Adult Patients With Extensive-Stage Small Cell Lung Cancer (Es-Sclc). ( 1.3 ) 1.1 Urothelial Carcinoma Imfinzi Is Indicated For The Treatment Of Adult Patients With Locally Advanced Or Metastatic Urothelial Carcinoma Who: • Have Disease Progression During Or Following Platinum-Containing Chemotherapy. • Have Disease Progression Within 12 Months Of Neoadjuvant Or Adjuvant Treatment With Platinum-Containing Chemotherapy. This Indication Is Approved Under Accelerated Approval Based On Tumor Response Rate And Duration Of Response. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials [See Clinical Studies (14.1) ] . 1.2 Non-Small Cell Lung Cancer Imfinzi Is Indicated For The Treatment Of Adult Patients With Unresectable Stage Iii Non-Small Cell Lung Cancer (Nsclc) Whose Disease Has Not Progressed Following Concurrent Platinum-Based Chemotherapy And Radiation Therapy . 1.3 Small Cell Lung Cancer Imfinzi, In Combination With Etoposide And Either Carboplatin Or Cisplatin, Is Indicated For The First-Line Treatment Of Adult Patients With Extensive-Stage Small Cell Lung Cancer (Es-Sclc).
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