# OnCo record nivolumab (drug). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
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a schema:Drug ;
onco:kind "drug" ;
schema:identifier "nivolumab" ;
schema:name "Nivolumab"@en ;
schema:description "Nivolumab was the second PD-1 blocker and is often combined with ipilimumab. Long-term data show about half of advanced melanoma patients alive at 10 years on the combination."@en ;
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schema:dateModified "2026-09-04"^^xsd:date ;
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onco:status "approved" ;
onco:modality "Monoclonal antibody (anti-PD-1)" ;
schema:alternateName "Opdivo / Opdivo Qvantig (SC)" ;
onco:approval "US 2014: Melanoma", "US 2026: Untreated advanced classical Hodgkin lymphoma with AVD, age ≥12", "US 2025: Unresectable or metastatic MSI-high or dMMR colorectal cancer, with ipilimumab", "England (NICE) 2025: Untreated unresectable or metastatic MSI-high or dMMR colorectal cancer, with ipilimumab", "England (NICE) 2020: Locally advanced or metastatic squamous non-small-cell lung cancer after chemotherapy", "England (NICE) 2021: Locally advanced or metastatic PD-L1-positive non-squamous non-small-cell lung cancer after chemotherapy", "England (NICE) 2021: Untreated metastatic non-small-cell lung cancer without an EGFR or ALK alteration, with ipilimumab and two cycles of platinum doublet chemotherapy: not recommended", "England (NICE) 2023: Neoadjuvant treatment of resectable non-small-cell lung cancer (4 cm or more, or node positive), with chemotherapy", "England (NICE) 2026: Resectable non-small-cell lung cancer at high risk of recurrence without an EGFR mutation or ALK rearrangement: neoadjuvant with platinum chemotherapy then adjuvant alone" ;
onco:acceleratedApproval "US 2014-12-22: Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor", "US 2015-09-30: In combination with ipilimumab for BRAF V600 wild-type unresectable or metastatic melanoma", "US 2016-01-23: 1) In combination with ipilimumab for unresectable or metastatic melanoma to remove the restriction for treatment of only patients with BRAF wild-type melanoma; 2) As a single agent for BRAF V600 mutation positive unresectable or metastatic melanoma to remove the restriction that such patients should have disease progression following ipilimumab and a BRAF inhibitor", "US 2016-05-17: For the treatment of classical Hodgkin Lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin", "US 2017-02-02: Locally advanced or metastatic urothelial carcinoma that: • progressed during or following platinum-containing chemotherapy • progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy", "US 2017-04-25: Treatment of adult patients with classical Hodgkin lymphoma 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", "US 2017-07-31: 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", "US 2017-09-22: Hepatocellular carcinoma previously treated with sorafenib", "US 2018-07-10: In combination with ipilimumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan", "US 2018-08-16: Metastatic SCLC with progression after platinum-based chemotherapy and at least one other line of therapy", "US 2020-03-10: In combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib", "US 2024-12-27: Formulation: As monotherapy or as monotherapy following treatment with intravenous nivolumab and ipilimumab combination therapy for the treatment of adult 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 .", "US 2024-12-27: Formulation: Treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib and following treatment with intravenous nivolumab and ipilimumab ." ;
onco:acceleratedApprovalConfirmed "US 2019-03-07: Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor", "US 2019-03-07: In combination with ipilimumab for BRAF V600 wild-type unresectable or metastatic melanoma", "US 2019-03-07: 1) In combination with ipilimumab for unresectable or metastatic melanoma to remove the restriction for treatment of only patients with BRAF wild-type melanoma; 2) As a single agent for BRAF V600 mutation positive unresectable or metastatic melanoma to remove the restriction that such patients should have disease progression following ipilimumab and a BRAF inhibitor", "US 2021-08-19: Locally advanced or metastatic urothelial carcinoma that: • progressed during or following platinum-containing chemotherapy • progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy", "US 2025-04-08: 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", "US 2025-04-08: In combination with ipilimumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan", "US 2025-04-11: In combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib", "US 2025-10-27: Formulation: As monotherapy or as monotherapy following treatment with intravenous nivolumab and ipilimumab combination therapy for the treatment of adult 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 .", "US 2025-10-27: Formulation: Treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib and following treatment with intravenous nivolumab and ipilimumab .", "US 2026-03-20: For the treatment of classical Hodgkin Lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin", "US 2026-03-20: Treatment of adult patients with classical Hodgkin lymphoma 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" ;
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