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1 Indications And Usage Opdivo Is A Programmed Death Receptor-1 (Pd-1) Blocking Antibody Indicated For The Treatment Of: Melanoma • Patients With Unresectable Or Metastatic Melanoma, As A Single Agent Or In Combination With Ipilimumab. (1.1) • Patients With Melanoma With Lymph Node Involvement Or Metastatic Disease Who Have Undergone Complete Resection, In The Adjuvant Setting. (1.2) Non-Small Cell Lung Cancer (Nsclc) • Adult Patients With Metastatic Non-Small Cell Lung Cancer Expressing Pd-L1 (≥1%) As Determined By An Fda-Approved Test, With No Egfr Or Alk Genomic Tumor Aberrations, As First-Line Treatment In Combination With Ipilimumab. (1.3) • Adult Patients With Metastatic Or Recurrent Non-Small Cell Lung Cancer With No Egfr Or Alk Genomic Tumor Aberrations As First-Line Treatment, In Combination With Ipilimumab And 2 Cycles Of Platinum-Doublet Chemotherapy. (1.3) • Patients With Metastatic Non-Small Cell Lung Cancer And Progression On Or After Platinum-Based Chemotherapy. Patients With Egfr Or Alk Genomic Tumor Aberrations Should Have Disease Progression On Fda-Approved Therapy For These Aberrations Prior To Receiving Opdivo. (1.3) Small Cell Lung Cancer (Sclc) • Patients With Metastatic Small Cell Lung Cancer With Progression After Platinum-Based Chemotherapy And At Least One Other Line Of Therapy. A (1.4) Renal Cell Carcinoma (Rcc) • Patients With Advanced Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy. (1.5) • Patients With Intermediate Or Poor Risk, Previously Untreated Advanced Renal Cell Carcinoma, In Combination With Ipilimumab. (1.5) Classical Hodgkin Lymphoma (Chl) • Adult Patients With Classical Hodgkin Lymphoma That Has Relapsed Or Progressed After A : (1.6) • Autologous Hematopoietic Stem Cell Transplantation (Hsct) And Brentuximab Vedotin, Or • 3 Or More Lines Of Systemic Therapy That Includes Autologous Hsct. Squamous Cell Carcinoma Of The Head And Neck (Scchn) • Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck With Disease Progression On Or After A Platinum-Based Therapy. (1.7) Urothelial Carcinoma • Patients With Locally Advanced Or Metastatic Urothelial Carcinoma Who A : • Have Disease Progression During Or Following Platinum-Containing Chemotherapy • Have Disease Progression Within 12 Months Of Neoadjuvant Or Adjuvant Treatment With Platinum-Containing Chemotherapy. (1.8) Colorectal Cancer • Adult And Pediatric (12 Years And Older) Patients With Microsatellite Instability-High (Msi-H) Or Mismatch Repair Deficient (Dmmr) Metastatic Colorectal Cancer That Has Progressed Following Treatment With A Fluoropyrimidine, Oxaliplatin, And Irinotecan, As A Single Agent Or In Combination With Ipilimumab. A (1.9) Hepatocellular Carcinoma (Hcc) • Patients With Hepatocellular Carcinoma Who Have Been Previously Treated With Sorafenib, As A Single Agent Or In Combination With Ipilimumab. A (1.10) Esophageal Squamous Cell Carcinoma (Escc) • Patients With Unresectable Advanced, Recurrent Or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine- And Platinum-Based Chemotherapy. (1.11) A This Indication Is Approved Under Accelerated Approval Based On Overall 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 Unresectable Or Metastatic Melanoma Opdivo, As A Single Agent Or In Combination With Ipilimumab, Is Indicated For The Treatment Of Patients With Unresectable Or Metastatic Melanoma. 1.2 Adjuvant Treatment Of Melanoma Opdivo Is Indicated For The Adjuvant Treatment Of Patients With Melanoma With Involvement Of Lymph Nodes Or Metastatic Disease Who Have Undergone Complete Resection. 1.3 Metastatic Non-Small Cell Lung Cancer • Opdivo, In Combination With Ipilimumab, Is Indicated For The First-Line Treatment Of Adult Patients With Metastatic Non-Small Cell Lung Cancer (Nsclc) Whose Tumors Express Pd-L1 (≥1%) As Determined By An Fda-Approved Test [See Dosage And Administration (2.1) ] , With No Egfr Or Alk Genomic Tumor Aberrations. • Opdivo, In Combination With Ipilimumab And 2 Cycles Of Platinum-Doublet Chemotherapy, Is Indicated For The First-Line Treatment Of Adult Patients With Metastatic Or Recurrent Non-Small Cell Lung Cancer (Nsclc), With No Egfr Or Alk Genomic Tumor Aberrations. • Opdivo Is Indicated For The Treatment Of Patients With Metastatic Nsclc With Progression On Or After Platinum-Based Chemotherapy. Patients With Egfr Or Alk Genomic Tumor Aberrations Should Have Disease Progression On Fda-Approved Therapy For These Aberrations Prior To Receiving Opdivo. 1.4 Small Cell Lung Cancer Opdivo Is Indicated For The Treatment Of Patients With Metastatic Small Cell Lung Cancer (Sclc) With Progression After Platinum-Based Chemotherapy And At Least One Other Line Of Therapy. This Indication Is Approved Under Accelerated Approval Based On Overall Response Rate And Duration Of Response [See Clinical Studies (14.4) ] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. 1.5 Advanced Renal Cell Carcinoma • Opdivo As A Single Agent Is Indicated For The Treatment Of Patients With Advanced Renal Cell Carcinoma (Rcc) Who Have Received Prior Anti-Angiogenic Therapy. • Opdivo, In Combination With Ipilimumab, Is Indicated For The Treatment Of Patients With Intermediate Or Poor Risk, Previously Untreated Advanced Rcc. 1.6 Classical Hodgkin Lymphoma Opdivo Is Indicated For The Treatment Of Adult Patients With Classical Hodgkin Lymphoma (Chl) That Has Relapsed Or Progressed After: • Autologous Hematopoietic Stem Cell Transplantation (Hsct) And Brentuximab Vedotin, Or • 3 Or More Lines Of Systemic Therapy That Includes Autologous Hsct. This Indication Is Approved Under Accelerated Approval Based On Overall Response Rate [See Clinical Studies (14.6) ] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. 1.7 Squamous Cell Carcinoma Of The Head And Neck Opdivo Is Indicated For The Treatment Of Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck (Scchn) With Disease Progression On Or After Platinum-Based Therapy. 1.8 Urothelial Carcinoma Opdivo Is Indicated For The Treatment Of 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 [See Clinical Studies (14.8) ] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. 1.9 Microsatellite Instability-High Or Mismatch Repair Deficient Metastatic Colorectal Cancer Opdivo, As A Single Agent Or In Combination With Ipilimumab, Is Indicated For The Treatment Of Adult And Pediatric Patients 12 Years And Older With Microsatellite Instability-High (Msi-H) Or Mismatch Repair Deficient (Dmmr) Metastatic Colorectal Cancer (Crc) That Has Progressed Following Treatment With A Fluoropyrimidine, Oxaliplatin, And Irinotecan. This Indication Is Approved Under Accelerated Approval Based On Overall Response Rate And Duration Of Response [See Clinical Studies (14.9) ] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. 1.10 Hepatocellular Carcinoma Opdivo , As A Single Agent Or In Combination With Ipilimumab, Is Indicated For The Treatment Of Patients With Hepatocellular Carcinoma (Hcc) Who Have Been Previously Treated With Sorafenib. This Indication Is Approved Under Accelerated Approval Based On Overall Response Rate And Duration Of Response [See Clinical Studies (14.10) ] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In The Confirmatory Trials. 1.11 Esophageal Squamous Cell Carcinoma Opdivo Is Indicated For The Treatment Of Patients With Unresectable Advanced, Recurrent Or Metastatic Esophageal Squamous Cell Carcinoma (Escc) After Prior Fluoropyrimidine- And Platinum-Based Chemotherapy.
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