Drug Overview
Opdivo (nivolumab; Bristol-Myers Squibb/Ono Pharmaceutical) is a fully human immunoglobulin G4 PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells. PD-1 and its ligands, PD-L1 and PD-L2, are members of the cluster of differentiation 28 and B7 family.
The B7 family cell surface molecules and the cytotoxic T-lymphocyte antigen 4 family both regulate complex signaling pathways that affect T-cell activation, tolerance, and immunopathology. Blocking the interaction of the PD-1 receptor with its ligands may allow T cells to restore an anti-tumor immune response.
Opdivo (nivolumab; Bristol-Myers Squibb/Ono Pharmaceutical) is a fully human immunoglobulin G4 PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells. PD-1 and its ligands, PD-L1 and PD-L2, are members of the cluster of differentiation 28 and B7 family.
The B7 family cell surface molecules and the cytotoxic T-lymphocyte antigen 4 family both regulate complex signaling pathways that affect T-cell activation, tolerance, and immunopathology. Blocking the interaction of the PD-1 receptor with its ligands may allow T cells to restore an anti-tumor immune response.
Table of Contents
OVERVIEW
- Drug Overview
- Product Profiles
- Opdivo : Hepatocellular carcinoma (HCC)
- Opdivo : Renal cell carcinoma (RCC)
- Opdivo : Non-small cell lung cancer (NSCLC)
- Opdivo : Melanoma
- Opdivo : Gastric cancer
- Opdivo : Colorectal cancer (CRC)
- Opdivo : Head and neck cancer
- Opdivo : Bladder cancer
LIST OF FIGURES
Figure 1: The author's drug assessment summary of Opdivo for HCC
Figure 2: The author's drug assessment summary of Opdivo for HCC
Figure 3: Opdivo sales for HCC across the US and five major EU markets, by country, 2018–27
Figure 4: Opdivo for RCC – SWOT analysis
Figure 5: The author's drug assessment summary of Opdivo for RCC
Figure 6: The author's drug assessment summary of Opdivo for RCC
Figure 7: Opdivo sales for RCC across the US, Japan, and five major EU markets, by country, 2017–26
Figure 8: Opdivo for non-small cell lung cancer – SWOT analysis
Figure 9: The author's drug assessment summary for Opdivo in non-small cell lung cancer
Figure 10: The author's drug assessment summary for Opdivo in non-small cell lung cancer
Figure 11: Opdivo sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
Figure 12: Opdivo for melanoma – SWOT analysis
Figure 13: The author's drug assessment summary of Opdivo for melanoma
Figure 14: The author's drug assessment summary of Opdivo for melanoma
Figure 15: Opdivo sales for melanoma across the US, Japan, and five major EU markets, by country, 2017–26
Figure 16: Opdivo for gastric cancer – SWOT analysis
Figure 17: The author's drug assessment summary of Opdivo for gastric cancer
Figure 18: The author's drug assessment summary of Opdivo for gastric cancer
Figure 19: Opdivo sales for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
Figure 20: Opdivo for colorectal cancer – SWOT analysis
Figure 21: The author's drug assessment summary of Opdivo for colorectal cancer
Figure 22: The author's drug assessment summary of Opdivo for colorectal cancer
Figure 23: Opdivo sales for colorectal cancer across the US and five major EU markets, by country, 2016–25
Figure 24: Opdivo for head and neck cancer – SWOT analysis
Figure 25: The author's drug assessment summary of Opdivo for SCCHN
Figure 26: The author's drug assessment summary of Opdivo for SCCHN
Figure 27: Opdivo sales for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
Figure 28: Opdivo for urothelial bladder cancer – SWOT analysis
Figure 29: The author's drug assessment summary for Opdivo in urothelial bladder cancer
Figure 30: The author's drug assessment summary for Opdivo in urothelial bladder cancer
Figure 2: The author's drug assessment summary of Opdivo for HCC
Figure 3: Opdivo sales for HCC across the US and five major EU markets, by country, 2018–27
Figure 4: Opdivo for RCC – SWOT analysis
Figure 5: The author's drug assessment summary of Opdivo for RCC
Figure 6: The author's drug assessment summary of Opdivo for RCC
Figure 7: Opdivo sales for RCC across the US, Japan, and five major EU markets, by country, 2017–26
Figure 8: Opdivo for non-small cell lung cancer – SWOT analysis
Figure 9: The author's drug assessment summary for Opdivo in non-small cell lung cancer
Figure 10: The author's drug assessment summary for Opdivo in non-small cell lung cancer
Figure 11: Opdivo sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
Figure 12: Opdivo for melanoma – SWOT analysis
Figure 13: The author's drug assessment summary of Opdivo for melanoma
Figure 14: The author's drug assessment summary of Opdivo for melanoma
Figure 15: Opdivo sales for melanoma across the US, Japan, and five major EU markets, by country, 2017–26
Figure 16: Opdivo for gastric cancer – SWOT analysis
Figure 17: The author's drug assessment summary of Opdivo for gastric cancer
Figure 18: The author's drug assessment summary of Opdivo for gastric cancer
Figure 19: Opdivo sales for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
Figure 20: Opdivo for colorectal cancer – SWOT analysis
Figure 21: The author's drug assessment summary of Opdivo for colorectal cancer
Figure 22: The author's drug assessment summary of Opdivo for colorectal cancer
Figure 23: Opdivo sales for colorectal cancer across the US and five major EU markets, by country, 2016–25
Figure 24: Opdivo for head and neck cancer – SWOT analysis
Figure 25: The author's drug assessment summary of Opdivo for SCCHN
Figure 26: The author's drug assessment summary of Opdivo for SCCHN
Figure 27: Opdivo sales for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
Figure 28: Opdivo for urothelial bladder cancer – SWOT analysis
Figure 29: The author's drug assessment summary for Opdivo in urothelial bladder cancer
Figure 30: The author's drug assessment summary for Opdivo in urothelial bladder cancer
LIST OF TABLES
Table 1: Recent high-impact events for Opdivo in HCC
Table 2: Opdivo drug profile
Table 3: Approval history of Opdivo for HCC in the US, Japan, and five major EU markets
Table 4: Trials of Opdivo for HCC
Table 5: Opdivo for HCC – SWOT analysis
Table 6: Opdivo drug profile
Table 7: Opdivo Phase III data in RCC
Table 8: Opdivo ongoing trials in RCC
Table 9: Opdivo sales for RCC across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 10: Opdivo drug profile
Table 11: Opdivo pivotal trial data in non-small cell lung cancer
Table 12: Opdivo CheckMate-026 Phase III data in non-small cell lung cancer
Table 13: Opdivo ongoing late-phase clinical trials in non-small cell lung cancer
Table 14: Opdivo sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 15: Opdivo patient numbers for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
Table 16: Opdivo drug profile
Table 17: Opdivo pivotal trial data in melanoma
Table 18: Opdivo ongoing late-phase clinical trials in melanoma
Table 19: Opdivo sales for melanoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 20: Opdivo patient numbers for melanoma across the US, Japan, and five major EU markets, by country, 2017–26
Table 21: Opdivo drug profile
Table 22: Opdivo pivotal trial data in gastric cancer
Table 23: Opdivo Phase III trials in gastric cancer
Table 24: Opdivo sales for gastric cancer across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 25: Opdivo patient numbers for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
Table 26: Opdivo drug profile
Table 27: Opdivo pivotal trial data in colorectal cancer
Table 28: Opdivo early-phase trials in colorectal cancer
Table 29: Opdivo sales for colorectal cancer across the US and five major EU markets, by country ($m), 2016–25
Table 30: Patients treated with Opdivo across the US and five major EU markets, by country, 2016–25
Table 31: Opdivo drug profile
Table 32: Opdivo pivotal trial data in head and neck cancer
Table 33: Opdivo ongoing late-phase trials in head and neck cancer
Table 34: Opdivo sales for SCCHN across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 35: Opdivo patient numbers for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
Table 36: Opdivo drug profile
Table 37: Opdivo pivotal trial data in urothelial bladder cancer
Table 38: Opdivo ongoing late-phase trials in urothelial bladder cancer
Table 2: Opdivo drug profile
Table 3: Approval history of Opdivo for HCC in the US, Japan, and five major EU markets
Table 4: Trials of Opdivo for HCC
Table 5: Opdivo for HCC – SWOT analysis
Table 6: Opdivo drug profile
Table 7: Opdivo Phase III data in RCC
Table 8: Opdivo ongoing trials in RCC
Table 9: Opdivo sales for RCC across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 10: Opdivo drug profile
Table 11: Opdivo pivotal trial data in non-small cell lung cancer
Table 12: Opdivo CheckMate-026 Phase III data in non-small cell lung cancer
Table 13: Opdivo ongoing late-phase clinical trials in non-small cell lung cancer
Table 14: Opdivo sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 15: Opdivo patient numbers for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
Table 16: Opdivo drug profile
Table 17: Opdivo pivotal trial data in melanoma
Table 18: Opdivo ongoing late-phase clinical trials in melanoma
Table 19: Opdivo sales for melanoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 20: Opdivo patient numbers for melanoma across the US, Japan, and five major EU markets, by country, 2017–26
Table 21: Opdivo drug profile
Table 22: Opdivo pivotal trial data in gastric cancer
Table 23: Opdivo Phase III trials in gastric cancer
Table 24: Opdivo sales for gastric cancer across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 25: Opdivo patient numbers for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
Table 26: Opdivo drug profile
Table 27: Opdivo pivotal trial data in colorectal cancer
Table 28: Opdivo early-phase trials in colorectal cancer
Table 29: Opdivo sales for colorectal cancer across the US and five major EU markets, by country ($m), 2016–25
Table 30: Patients treated with Opdivo across the US and five major EU markets, by country, 2016–25
Table 31: Opdivo drug profile
Table 32: Opdivo pivotal trial data in head and neck cancer
Table 33: Opdivo ongoing late-phase trials in head and neck cancer
Table 34: Opdivo sales for SCCHN across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 35: Opdivo patient numbers for SCCHN across the US, Japan, and five major EU markets, by country, 2017–26
Table 36: Opdivo drug profile
Table 37: Opdivo pivotal trial data in urothelial bladder cancer
Table 38: Opdivo ongoing late-phase trials in urothelial bladder cancer
