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PMID
Authors
Title Opdivo (nivolumab) FDA Drug Label
Journal
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Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Nivolumab Opdivo MDX-1106|BMS-936558 Immune Checkpoint Inhibitor 94 PD-L1/PD-1 antibody 63 Opdivo (nivolumab) is an antibody that targets PD-1 (PDCD1), which results in increased T-cell activation and enhanced anti-tumor immune response (PMID: 28891423). Opdivo (nivolumab) is FDA approved for use as a monotherapy in patients with non-small cell lung cancer, small cell lung cancer, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, and esophageal squamous cell carcinoma, as a monotherapy or in combination with Yervoy (ipilimumab) in patients with melanoma, renal cell carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (including patients 12 years or older), and hepatocellular carcinoma, in combination with Yervoy (ipilimumab) as first-line therapy in patients with PD-L1-positive (>=1%) metastatic non-small cell lung cancer without EGFR or ALK alterations, and in combination with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy in patients with metastatic or recurrent non-small cell lung cancer without EGFR or ALK alterations (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown head and neck squamous cell carcinoma not applicable Nivolumab FDA approved Actionable In a Phase III clinical trial (CheckMate 141) that supported FDA approval, treatment with Opdivo (nivolumab) resulted in a 1 year overall survival rate of 36%, compared to 18% with standard therapy, and an improved median overall survival of 7.5 months, compared to 5.1 months with standard therapy, in patients with recurrent head and neck squamous cell carcinoma (PMID: 27718784; NCT02105636). detail... 27718784
Unknown unknown melanoma not applicable Ipilimumab + Nivolumab FDA approved Actionable In a Phase III trial (CheckMate 067) that supported FDA approval, combination of Opdivo (nivolumab) and Yervoy (ipilimumab) and Opdivo (nivolumab) alone demonstrated improved efficacy compared to Yervoy (ipilimumab) in patients with untreated advanced melanoma, resulted in a median overall survival unreached in the combination arm, 36.9 and 19.9 months in nivolumab and ipilimumab monotherapy arms, and a median progression-free survival of 11.5, 6.9, and 2.9 months respectively (PMID: 30361170; NCT01844505). detail... detail... 30361170
Unknown unknown melanoma not applicable Nivolumab FDA approved Actionable In a Phase III trial (CheckMate 037) that supported FDA approval, 31.7% (38/120) of patients with advanced melanoma treated with Opdivo (nivolumab) experienced an objective response whereas only 10.6% (5/47) of advanced melanoma patients treated with investigator's choice of therapy demonstrated an objective response (PMID: 25795410; NCT01721746). 25795410 detail...
Unknown unknown lung non-small cell carcinoma not applicable Nivolumab FDA approved Actionable In a Phase III trial (CheckMate 017) that supported FDA approval, squamous non-small cell lung carcinoma patients treated with Opdivo (nivolumab) demonstrated a greater overall survival (9.2 mo vs 6.0 mo), response rate (20% vs 9%), and progression-free survival (3.5 mo vs 2.8 mo) when compared to treatment with Taxotere (docetaxel), regardless of CD274 (PD-L1) expression level (PMID: 26028407; NCT01642004). 26028407 detail...
Unknown unknown hepatocellular carcinoma not applicable Nivolumab FDA approved Actionable In a Phase I/II trial (CheckMate 040) that supproted FDA approval, Opdivo (nivolumab) treatment resulted in complete response in 1% (3/214), partial response in 18% (39/214), and stable disease in 45% (96/214) of hepatocellular carcinoma patients (PMID: 28434648; NCT01658878). detail... 28434648
Unknown unknown renal cell carcinoma not applicable Nivolumab FDA approved Actionable In a Phase III clinical trial (CheckMate 025) that supported FDA approval, treatment with Opdivo (nivolumab) resulted in a median overall survival of 25 months, compared to 19.6 months with Afinitor (everolimus) and an objective response rate of 25% versus 5% with Afinitor (everolimus) in patients with advanced renal cell carcinoma (PMID: 26406148; NCT01668784). 26406148 detail...
Unknown unknown Hodgkin's lymphoma not applicable Nivolumab FDA approved Actionable In a Phase I trial (CheckMate 039) that supported FDA approval, treatment with Opdivo (nivolumab) resulted in an objective response rate of 87% (20/23), with complete response in 17% (4/23) and partial response in 70% (16/23) of patients with relapsed or refractory classical Hodgkin's lymphoma (PMID: 25482239; NCT01592370). 25482239 detail...
Unknown unknown esophagus squamous cell carcinoma not applicable Nivolumab FDA approved Actionable In a Phase III trial (ATTRACTION-3) that supported FDA approval, Opdivo (nivolumab) treatment demonstrated favorable safety profile and significantly improved median overall survival (10.9 vs 8.4 mo, HR=0.77, p=0.019) compared to chemotherapy in patients with advanced esophageal squamous cell carcinoma refractory or intolerant to prior chemotherapy (PMID: 31582355; NCT02569242). 31582355 detail...
Unknown unknown colorectal cancer not applicable Nivolumab FDA approved Actionable In a Phase II trial (CheckMate 142) that supported FDA approval, treatment with Opdivo (nivolumab) resulted in an objective response rate of 36% (19/53), with 1 complete response and 18 partial responses, and disease control for 12 weeks or more in 70% (37/53) of patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer (PMID: 28734759; NCT02060188). 28734759 detail...
Unknown unknown transitional cell carcinoma not applicable Nivolumab FDA approved Actionable In a Phase II trial (CheckMate 275) that supported FDA approval, treatment with Opdivo (nivolumab) resulted in objective response in 19.6% (52/265) of urothelial carcinoma patients with prior platinum therapy, with complete response in 2% (6/265), and partial response in 17% (46/265) of patients (PMID: 28131785; NCT02387996). detail... 28131785
Unknown unknown hepatocellular carcinoma not applicable Ipilimumab + Nivolumab FDA approved Actionable In a Phase I (CheckMate 040) trial that supported FDA approval, combination of Opdivo (nivolumab) and Yervoy (ipilimumab) was well tolerated, resulted in an objective response rate of 32% (16/50, 4 complete response, 12 partial response) with a median duration of response of 17 months in patients with hepatocellular carcinoma previously treated with Nexavar (sorafenib) (J Clin Oncol 37, no. 15_suppl (May 20, 2019) 4012-4012; NCT01658878). detail... detail... detail...
Unknown unknown lung non-small cell carcinoma not applicable Nivolumab FDA approved Actionable In a Phase III trial (CheckMate 057) that supported FDA approval, nonsquamous non-small cell lung carcinoma patients treated with Opdivo (nivolumab) demonstrated a greater overall survival (12.2 vs 9.4 months, HR=0.73, p=0.002) when compared to treatment with Taxotere (docetaxel) (PMID: 26412456; NCT01673867). detail... 26412456
Unknown unknown hepatocellular carcinoma not applicable Nivolumab FDA approved Actionable In a Phase I/II trial that supported FDA approval, Opdivo (nivolumab) treatment resulted in complete response in 1.9% (3/154) and partial response in 12.3% (19/154) of hepatocellular carcinoma patients who progressed on or were intolerant to Nexavar (sorafenib) (J Clin Oncol 35, 2017 (suppl; abstr 4013); NCT01658878). detail... detail...
Unknown unknown lung small cell carcinoma not applicable Nivolumab FDA approved Actionable In a Phase I/II trial (CheckMate 032) that supported FDA approval, Opdivo (nivolumab) as third- or later-line treatment resulted in an objective response rate of 11.9% (13/109, 1 complete response, 12 partial response) in patients with metastatic small cell lung cancer, with a median duration of response of 17.9 months (PMID: 29731394, PMID: 30316010; NCT01928394). 29731394 30316010 detail...
Unknown unknown renal cell carcinoma not applicable Ipilimumab + Nivolumab FDA approved Actionable In a Phase III trial (CheckMate 214) that supported FDA approval, the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) resulted in improved median overall survival (not reached vs. 26.0 months), objective response rate (42%, 40 complete responses (CR), vs. 27%, 5 CR), and progression-free survival (11.6 vs 8.4 months) compared to Sutent (sunitinib) in patients with intermediate or poor risk renal cell carcinoma (PMID: 29562145; NCT02231749). 29562145 detail... detail...
Unknown unknown melanoma not applicable Nivolumab FDA approved Actionable In a Phase III trial (CheckMate 238) that supported FDA approval, adjuvant Opdivo (nivolumab) treatment resulted in improved rate of recurrence-free survival at 12-month compared to Yervoy (ipilimumab) (70.5% vs 60.8%, HR=0.65, P<0.001) in patients with resected stage III or IV melanoma (PMID: 28891423, NCT02388906). detail... 28891423