Difference between revisions of "Nivolumab (Opdivo)"

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==General information==
 
==General information==
 
Class/mechanism: PD-1 receptor antibody. Nivolumab is an IgG4 kappa human monoclonal antibody which binds to the PD-1 (programmed death receptor-1) receptor and blocks its interaction with the ligands PD-L1 and PD-L2.  Normally, PD-L1 and PD-L2 binding to the PD-1 receptor on T cells inhibits T-cell proliferation and cytokine production, which can impede immune system surveillance of tumors.  By interfering with the binding of PD-L1 and PD-L2 to the PD-1 receptor, nivolumab can cause upregulation of the anti-tumor immune response.<ref name=insert>[http://packageinserts.bms.com/pi/pi_opdivo.pdf Nivolumab (Opdivo) package insert]</ref><ref>[[:File:Nivolumab.pdf | Nivolumab (Opdivo) package insert (locally hosted backup)]]</ref><ref>[http://www.opdivo.com/ Opdivo manufacturer's website]</ref>
 
Class/mechanism: PD-1 receptor antibody. Nivolumab is an IgG4 kappa human monoclonal antibody which binds to the PD-1 (programmed death receptor-1) receptor and blocks its interaction with the ligands PD-L1 and PD-L2.  Normally, PD-L1 and PD-L2 binding to the PD-1 receptor on T cells inhibits T-cell proliferation and cytokine production, which can impede immune system surveillance of tumors.  By interfering with the binding of PD-L1 and PD-L2 to the PD-1 receptor, nivolumab can cause upregulation of the anti-tumor immune response.<ref name=insert>[http://packageinserts.bms.com/pi/pi_opdivo.pdf Nivolumab (Opdivo) package insert]</ref><ref>[[:File:Nivolumab.pdf | Nivolumab (Opdivo) package insert (locally hosted backup)]]</ref><ref>[http://www.opdivo.com/ Opdivo manufacturer's website]</ref>
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==Diseases for which it is established ''(work in progress)''==
 
==Diseases for which it is established ''(work in progress)''==
−
*[[Bladder cancer]]
 
 
*[[Carcinoma of unknown primary]]
 
*[[Carcinoma of unknown primary]]
 
*[[Esophageal cancer]]
 
*[[Esophageal cancer]]
Line 26: Line 29:
 
*[[Renal cell carcinoma]]
 
*[[Renal cell carcinoma]]
 
**[[Clear cell renal cell carcinoma]]
 
**[[Clear cell renal cell carcinoma]]
 +
*[[Urothelial carcinoma]]
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
Line 38: Line 42:
 
==Patient drug information==
 
==Patient drug information==
 
*[http://packageinserts.bms.com/pi/pi_opdivo.pdf Nivolumab (Opdivo) package insert]<ref name="insert"></ref>
 
*[http://packageinserts.bms.com/pi/pi_opdivo.pdf Nivolumab (Opdivo) package insert]<ref name="insert"></ref>
−
*[https://chemocare.com/chemotherapy/drug-info/Nivolumab.aspx Nivolumab (Opdivo) patient drug information (Chemocare)]<ref>[https://chemocare.com/chemotherapy/drug-info/Nivolumab.aspx Nivolumab (Opdivo) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/Nivolumab.aspx Nivolumab (Opdivo) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/Nivolumab.aspx Nivolumab (Opdivo) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/nivolumab-patient-drug-information Nivolumab (Opdivo) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/nivolumab-patient-drug-information Nivolumab (Opdivo) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/nivolumab-patient-drug-information Nivolumab (Opdivo) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/nivolumab-patient-drug-information Nivolumab (Opdivo) patient drug information (UpToDate)]</ref>
  
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==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
===[[Bladder cancer]]===
 
−
*2017-02-02: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm539646.htm Granted accelerated approval] for treatment of patients with locally advanced or metastatic [[Bladder cancer|urothelial carcinoma]] who have disease progression during or following  [[Regimen_classes#Platinum-based_regimen|platinum-containing chemotherapy]]. ''(New disease entity; based on CheckMate 275)''
 
−
*2017-02-02: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm539646.htm Granted accelerated approval] for treatment of patients with [[Bladder cancer|urothelial carcinoma]] who have disease progression within 12 months of neoadjuvant or adjuvant treatment with a [[Regimen_classes#Platinum-based_regimen|platinum-containing chemotherapy]]. ''(New disease entity; based on CheckMate 275)''
 
−
*2021-08-19: Full approval for the adjuvant treatment of patients with [[Bladder cancer|urothelial carcinoma (UC)]] who are at high risk of recurrence after undergoing radical resection. ''(Extended to adjuvant setting; converted to regular approval; based on CheckMate 274)''
 
  
 
===[[Classical Hodgkin lymphoma]]===
 
===[[Classical Hodgkin lymphoma]]===
Line 58: Line 58:
  
 
===[[Esophageal cancer]]===
 
===[[Esophageal cancer]]===
 +
*2021-05-20: Approved for patients with completely resected [[Esophageal cancer|esophageal]] or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. ''(Based on CheckMate 577)''
 +
 +
====[[Esophageal adenocarcinoma]]====
 +
*2021-04-16: Approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and [[esophageal adenocarcinoma]]. ''(Based on CheckMate 649)''
 +
====[[Esophageal squamous cell carcinoma]]====
 
*2020-06-10: for patients with unresectable advanced, recurrent or metastatic [[Esophageal squamous cell carcinoma|esophageal squamous cell carcinoma (ESCC)]] after prior fluoropyrimidine- and platinum-based chemotherapy. ''(New disease entity; based on ATTRACTION-3)''
 
*2020-06-10: for patients with unresectable advanced, recurrent or metastatic [[Esophageal squamous cell carcinoma|esophageal squamous cell carcinoma (ESCC)]] after prior fluoropyrimidine- and platinum-based chemotherapy. ''(New disease entity; based on ATTRACTION-3)''
−
*2021-04-16: Approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and [[esophageal adenocarcinoma]]. ''(Based on CheckMate 649)''
 
−
*2021-05-20: Approved for patients with completely resected [[Esophageal cancer|esophageal]] or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. ''(Based on CheckMate 577)''
 
 
*2022-05-27: Approved for the first-line treatment of patients with advanced or metastatic [[Esophageal squamous cell carcinoma|esophageal squamous cell carcinoma (ESCC)]] in combination with fluoropyrimidine- and platinum-based chemotherapy. ''(Based on CheckMate 648)''
 
*2022-05-27: Approved for the first-line treatment of patients with advanced or metastatic [[Esophageal squamous cell carcinoma|esophageal squamous cell carcinoma (ESCC)]] in combination with fluoropyrimidine- and platinum-based chemotherapy. ''(Based on CheckMate 648)''
 
*2022-05-27: Approved for the first-line treatment of patients with advanced or metastatic [[Esophageal squamous cell carcinoma|esophageal squamous cell carcinoma (ESCC)]] in combination with ipilimumab. ''(Based on CheckMate 648)''
 
*2022-05-27: Approved for the first-line treatment of patients with advanced or metastatic [[Esophageal squamous cell carcinoma|esophageal squamous cell carcinoma (ESCC)]] in combination with ipilimumab. ''(Based on CheckMate 648)''
Line 72: Line 75:
 
===[[Hepatocellular carcinoma]] - '''PARTIALLY WITHDRAWN'''===
 
===[[Hepatocellular carcinoma]] - '''PARTIALLY WITHDRAWN'''===
 
*2017-09-22: Granted FDA accelerated approval for the treatment of [[Hepatocellular carcinoma|hepatocellular carcinoma (HCC)]] in patients who have been previously treated with [[Sorafenib (Nexavar)|sorafenib]]. ''(New disease entity; based on CheckMate 040)''
 
*2017-09-22: Granted FDA accelerated approval for the treatment of [[Hepatocellular carcinoma|hepatocellular carcinoma (HCC)]] in patients who have been previously treated with [[Sorafenib (Nexavar)|sorafenib]]. ''(New disease entity; based on CheckMate 040)''
−
**2021-07-23: Approval withdrawn. ''(Based on CheckMate 459)''
+
**2021-07-23: Accelerated approval withdrawn. ''(Based on CheckMate 459)''
−
*2020-03-10: Accelerated approval in combination with ipilimumab for patients with [[hepatocellular carcinoma|hepatocellular carcinoma (HCC)]] who have been previously treated with sorafenib. ''(Approval extended to combination therapy; based on CheckMate 040)''
+
*2020-03-10: Accelerated approval in combination with ipilimumab for patients with [[hepatocellular carcinoma|hepatocellular carcinoma (HCC)]] who have been previously treated with sorafenib. ''(Approval extended to combination therapy; based on CheckMate 040<sub>combo</sub>)''
  
 
===[[Malignant pleural mesothelioma]]===
 
===[[Malignant pleural mesothelioma]]===
Line 84: Line 87:
 
**2019-03-07: Converted to regular approval. ''(Based on CheckMate 037 & CheckMate 067)''
 
**2019-03-07: Converted to regular approval. ''(Based on CheckMate 037 & CheckMate 067)''
 
*2017-12-20: Granted regular approval for the adjuvant treatment of patients with [[melanoma]] with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. ''(Based on CheckMate 238)''
 
*2017-12-20: Granted regular approval for the adjuvant treatment of patients with [[melanoma]] with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. ''(Based on CheckMate 238)''
 +
*2023-10-13: Approved for the adjuvant treatment of completely resected Stage IIB/C [[melanoma]] in patients 12 years and older. ''(Based on CheckMate 76K)''
  
 
===[[Non-small cell lung cancer]]===
 
===[[Non-small cell lung cancer]]===
−
*2015-03-04: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm436566.htm Approved] for the treatment of patients with metastatic [[Non-small cell lung cancer, squamous | squamous non-small cell lung cancer (NSCLC)]] with progression on or after [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]. ''(New disease entity; based on CheckMate 017)
 
 
*2015-10-09: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm466576.htm Approval expanded] for the treatment of patients with metastatic [[Non-small cell lung cancer | non-small cell lung cancer (NSCLC)]] with progression on or after [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]. ''(Histology indication expanded to include nonsquamous; based on CheckMate 057)''
 
*2015-10-09: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm466576.htm Approval expanded] for the treatment of patients with metastatic [[Non-small cell lung cancer | non-small cell lung cancer (NSCLC)]] with progression on or after [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]. ''(Histology indication expanded to include nonsquamous; based on CheckMate 057)''
 
**Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo.
 
**Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo.
−
*2020-05-15: Approved in combination with [[Ipilimumab (Yervoy)|ipilimumab]] as first-line treatment for patients with metastatic [[non-small cell lung cancer]] whose tumors [[Biomarkers#Expression|express]] [[Biomarkers#PD-L1|PD-L1]] (≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. ''(Expanded to first-line setting, with PD-L1 expression requirement; based on CheckMate 227)''
+
*2020-05-15: Approved in combination with [[Ipilimumab (Yervoy)|ipilimumab]] as first-line treatment for patients with metastatic [[non-small cell lung cancer]] whose tumors [[Biomarkers#Expression|express]] [[Biomarkers#PD-L1|PD-L1]] (at least 1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. ''(Expanded to first-line setting, with PD-L1 expression requirement; based on CheckMate 227)''
 
*2020-05-26: Approved in combination with [[Ipilimumab (Yervoy)|ipilimumab]] and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]], with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. ''(PD-L1 expression requirement removed when given with chemotherapy; based on CheckMate 9LA)''
 
*2020-05-26: Approved in combination with [[Ipilimumab (Yervoy)|ipilimumab]] and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]], with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. ''(PD-L1 expression requirement removed when given with chemotherapy; based on CheckMate 9LA)''
 
*2022-03-04: Approved with platinum-doublet chemotherapy for adult patients with resectable [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] in the neoadjuvant setting. ''(Based on CheckMate 816)''
 
*2022-03-04: Approved with platinum-doublet chemotherapy for adult patients with resectable [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] in the neoadjuvant setting. ''(Based on CheckMate 816)''
 +
====[[Non-small cell lung cancer, squamous]]====
 +
*2015-03-04: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm436566.htm Approved] for the treatment of patients with metastatic [[Non-small cell lung cancer, squamous | squamous non-small cell lung cancer (NSCLC)]] with progression on or after [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]. ''(New disease entity; based on CheckMate 017)
  
 
===[[Renal cell carcinoma]]===
 
===[[Renal cell carcinoma]]===
Line 99: Line 104:
  
 
===[[Small cell lung cancer]] - '''WITHDRAWN'''===
 
===[[Small cell lung cancer]] - '''WITHDRAWN'''===
−
*2018-08-16: Granted FDA accelerated approval for patients with metastatic [[Small cell lung cancer|small cell lung cancer (SCLC)]] with progression after [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]] and at least one other line of therapy. ''(Based on CheckMate 032)''
+
*2018-08-16: Granted FDA accelerated approval for patients with metastatic [[Small cell lung cancer|small cell lung cancer (SCLC)]] with progression after [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]] and at least one other line of therapy. ''(Based on CheckMate 032<sub>SCLC</sub>)''
−
**2020-12-29: Approval withdrawn. ''(Based on CheckMate 331 & CheckMate 451)''
+
**2020-12-29: Accelerated approval withdrawn. ''(Based on CheckMate 331 & CheckMate 451)''
 +
 
 +
===[[Urothelial carcinoma]]===
 +
*2017-02-02: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm539646.htm Granted accelerated approval] for treatment of patients with locally advanced or metastatic [[urothelial carcinoma]] who have disease progression during or following  [[Regimen_classes#Platinum-based_regimen|platinum-containing chemotherapy]]. ''(New disease entity; based on CheckMate 275)''
 +
*2017-02-02: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm539646.htm Granted accelerated approval] for treatment of patients with [[urothelial carcinoma]] who have disease progression within 12 months of neoadjuvant or adjuvant treatment with a [[Regimen_classes#Platinum-based_regimen|platinum-containing chemotherapy]]. ''(New disease entity; based on CheckMate 275)''
 +
*2021-08-19: Full approval for the adjuvant treatment of patients with [[Urothelial carcinoma|urothelial carcinoma (UC)]] who are at high risk of recurrence after undergoing radical resection. ''(Extended to adjuvant setting; converted to regular approval; based on CheckMate 274)''
 +
*2024-03-06: Approved in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic [[Urothelial carcinoma|urothelial carcinoma (UC)]]. ''(Based on CheckMate 901 part 1)''
  
 
==History of changes in EMA indication==
 
==History of changes in EMA indication==
−
*2015-06-19: Initial marketing authorization as Opdivo.
+
===[[Colorectal cancer]]===
 +
*2021-06-24: Extension of indication to include the combination of nivolumab with ipilimumab in the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic [[colorectal cancer|colorectal cancer (CRC)]] after prior fluoropyrimidine based combination chemotherapy.
 +
===[[Esophageal cancer]]===
 +
*2021-07-28: Extension of indication to include adjuvant treatment of adult patients with [[Esophageal cancer|oesophageal]], or gastrooesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy for OPDIVO. ''(Based on CheckMate 577)''
 +
 
 +
====[[Esophageal squamous cell carcinoma]]====
 +
*2020-11-20: Extension of indication to include treatment of adult patients with unresectable advanced, recurrent or metastatic [[Esophageal squamous cell carcinoma|oesophageal squamous cell carcinoma (OSCC)]] after prior fluoropyrimidine- and platinumbased chemotherapy.
 +
*2022-04-01: Extension of indication to include treatment of firstline treatment of adult patients with unresectable advanced, recurrent or metastatic [[Esophageal squamous cell carcinoma|oesophageal squamous cell carcinoma (OSCC)]] with tumour cell PD-L1 expression at least 1% for Opdivo in combination with Yervoy.
 +
*20220-04-01: Extension of indication to include in combination with fluoropyrimidine- and platinum-based combination chemotherapy the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic [[Esophageal squamous cell carcinoma|oesophageal squamous cell carcinoma (OSCC)]] with tumour cell PD-L1 expression at least 1% for OPDIVO. ''(Based on CheckMate 648)''
 +
 
 +
===[[Gastric cancer]]===
 +
*2021-10-19: Extension of indication to use OPDIVO (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy, in first-line treatment of adult patients with HER2-negative advanced or metastatic [[gastric cancer|gastric]], gastro-oesophageal junction (GEJ) or [[Esophageal adenocarcinoma|oesophageal adenocarcinoma]] whose tumours express PD-L1 with a combined positive score (CPS) at least 5. ''(Based on CheckMate 649)''
 +
 
 +
===[[Head and neck cancer]]===
 +
*2017-04-28: Extension of Indication to include treatment of [[Head and neck cancer|squamous cell cancer of the head and neck (SCCHN)]] in adults progressing on or after platinum-based therapy for OPDIVO as monotherapy.
 +
 
 +
===[[Malignant pleural mesothelioma]]===
 +
*2021-06-01: Extension of indication to include first-line treatment of adult patients with unresectable [[malignant pleural mesothelioma|malignant pleural mesothelioma (MPM)]] for combination treatment of Opdivo and Yervoy.
 +
 
 +
===[[Melanoma]]===
 +
*2015-06-19: Initial marketing authorization as Opdivo. Opdivo as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) [[melanoma]] in adults.
 +
*2016-05-11: Extension of Indication to include treatment in combination with ipilimumab of advanced (unresectable or metastatic) [[melanoma]] in adults. ''(Based on CheckMate 067 & CheckMate 069)''
 +
*2018-07-30: Extension of Indication to include adjuvant treatment of adults with [[melanoma]] with involvement of lymph nodes or metastatic disease who have undergone complete resection. ''(Based on CheckMate 238)''
 +
*2023-06-16: Opdivo as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) [[melanoma]] in adults '''and adolescents 12 years of age and older'''.
 +
*2023-06-16: Opdivo in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) [[melanoma]] in adults '''and adolescents 12 years of age and older'''.
 +
*2023-06-16: Opdivo as monotherapy is indicated for the adjuvant treatment of adults and '''adolescents 12 years of age and older''' with [[melanoma]] with involvement of lymph nodes or metastatic disease who have undergone complete resection.
 +
*2023-08-21: Extension of indication to include OPDIVO for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC [[melanoma]] who have undergone complete resection. ''(Based on CheckMate 76K)''
 +
 
 +
===[[Non-small cell lung cancer]]===
 +
*2020-11-05: Extension of indication to include first-line treatment of metastatic [[non-small cell lung cancer]] in adults whose tumours have no sensitising EGFR mutation or ALK translocation for combination of OPDIVO/Yervoy and chemotherapy.
 +
*2023-06-26: Extension of indication to include OPDIVO in combination with platinum-based chemotherapy for neoadjuvant treatment of adult patients with resectable Stage IB-IIIA [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]]. ''(Based on CheckMate 816)''
 +
 
 +
====[[Non-small cell lung cancer, nonsquamous]]====
 +
*2016-04-04: Extension of Indication to include treatment as monotherapy of locally advanced or metastatic [[Non-small cell lung cancer, nonsquamous|nonsquamous NSCLC]] after prior chemotherapy in adults. ''(Based on CheckMate 057)''
 +
 
 +
====[[Non-small cell lung cancer, squamous]]====
 +
*2015-10-28: Extension of indication to include treatment of locally advanced or metastatic [[Non-small cell lung cancer, squamous|squamous non-small cell lung cancer (NSCLC)]] after prior chemotherapy in adults.
 +
 
 +
===[[Renal cell carcinoma]]===
 +
*2016-04-04: Extension of Indication to add treatment as monotherapy of patients with advanced [[Renal cell carcinoma|renal cell carcinoma (RCC)]] after prior therapy in adults. ''(Based on CheckMate 025)''
 +
*2019-01-11: Extension of indication to include the combination treatment with nivolumab and ipilimumab of adult patients with intermediate/poor-risk advanced [[renal cell carcinoma]].
 +
*2021-04-13: Extension of indication to include in combination with cabozantinib for the first line treatment of advanced [[renal cell carcinoma]] for Opdivo.
 +
 
 +
===[[Urothelial carcinoma]]===
 +
*2017-06-02: Extension of Indication to include the treatment of locally advanced unresectable or metastatic [[urothelial carcinoma]] in adults after failure of prior platinum-containing therapy for OPDIVO.
 +
*2022-04-01: Extension of indication for Opdivo to include as monotherapy for the adjuvant treatment of adults with muscle invasive [[urothelial carcinoma]] (MIUC) with tumour cell PD-L1 expression at least 1%, who are at high risk of recurrence after undergoing radical resection of MIUC.
  
 
==History of changes in Health Canada indication==
 
==History of changes in Health Canada indication==
Line 110: Line 166:
 
*2018-03-23: Notice of compliance with conditions as a monotherapy for the treatment of adult patients with advanced (not amenable to curative therapy or local therapeutic measures) or metastatic [[hepatocellular carcinoma|hepatocellular carcinoma (HCC)]] who are intolerant to or have progressed on sorafenib therapy.
 
*2018-03-23: Notice of compliance with conditions as a monotherapy for the treatment of adult patients with advanced (not amenable to curative therapy or local therapeutic measures) or metastatic [[hepatocellular carcinoma|hepatocellular carcinoma (HCC)]] who are intolerant to or have progressed on sorafenib therapy.
 
*2021-02-11: Notice of compliance with conditions in combination with ipilimumab. Indicated for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic [[colorectal cancer]] after prior fluoropyrimidine-based therapy in combination with oxaliplatin or irinotecan.
 
*2021-02-11: Notice of compliance with conditions in combination with ipilimumab. Indicated for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic [[colorectal cancer]] after prior fluoropyrimidine-based therapy in combination with oxaliplatin or irinotecan.
−
*2022-06-27: Notice of compliance with conditions as a monotherapy for the adjuvant treatment of adult patients with [[Bladder cancer|urothelial carcinoma (UC)]] who are at high risk of recurrence after undergoing radical resection of UC.
+
*2022-06-27: Notice of compliance with conditions as a monotherapy for the adjuvant treatment of adult patients with [[Urothelial carcinoma|urothelial carcinoma (UC)]] who are at high risk of recurrence after undergoing radical resection of UC.
 
==History of changes in PMDA indication==
 
==History of changes in PMDA indication==
−
===[[Bladder cancer]]===
 
−
*2022-03-28: New indication and a new dosage for the postoperative adjuvant therapy for [[Bladder cancer|urothelial carcinoma]].
 
 
===[[Carcinoma of unknown primary]]===
 
===[[Carcinoma of unknown primary]]===
−
*2021-12-24: New indication and a new dosage for the treatment of [[carcinoma of unknown primary]].
+
*2021-12-24: New indication and a new dosage for the treatment of [[carcinoma of unknown primary]]. ''(Based on Tanizaki et al. 2021)''
 
===[[Classical Hodgkin lymphoma]]===
 
===[[Classical Hodgkin lymphoma]]===
 
*2016-12-02: New additional indication for the treatment of relapsed or refractory [[Classical Hodgkin lymphoma|classical Hodgkin's lymphoma]].
 
*2016-12-02: New additional indication for the treatment of relapsed or refractory [[Classical Hodgkin lymphoma|classical Hodgkin's lymphoma]].
Line 129: Line 183:
 
===[[Head and neck cancer]]===
 
===[[Head and neck cancer]]===
 
*2017-03-24: New additional indication for the treatment of relapse or distant metastasis of [[head and neck cancer]].
 
*2017-03-24: New additional indication for the treatment of relapse or distant metastasis of [[head and neck cancer]].
 +
 +
===[[:Category:Mesotheliomas|Mesothelioma]]===
 +
*2023-11-24: New indication and a new dosage for the treatment of [[:Category:Mesotheliomas|malignant mesothelioma]] (excluding malignant pleural mesothelioma).
  
 
===[[Malignant pleural mesothelioma]]===
 
===[[Malignant pleural mesothelioma]]===
 
*2018-08-21: New indication and a new dosage for the treatment of unresectable or recurrent [[malignant pleural mesothelioma]] and melanoma that has progressed after chemotherapy.
 
*2018-08-21: New indication and a new dosage for the treatment of unresectable or recurrent [[malignant pleural mesothelioma]] and melanoma that has progressed after chemotherapy.
 
*2021-05-27: New indication and a new dosage for the treatment of unresectable advanced or recurrent [[malignant pleural mesothelioma]].
 
*2021-05-27: New indication and a new dosage for the treatment of unresectable advanced or recurrent [[malignant pleural mesothelioma]].
 +
 
===[[Melanoma]]===
 
===[[Melanoma]]===
 
*2014-07-04: Initial approval for the treatment of unresectable malignant [[melanoma]].
 
*2014-07-04: Initial approval for the treatment of unresectable malignant [[melanoma]].
Line 140: Line 198:
 
===[[Renal cell carcinoma]]===
 
===[[Renal cell carcinoma]]===
 
*2016-08-26: New additional indication for the treatment of unresectable or metastatic [[renal cell carcinoma]].
 
*2016-08-26: New additional indication for the treatment of unresectable or metastatic [[renal cell carcinoma]].
 +
===[[Urothelial carcinoma]]===
 +
*2022-03-28: New indication and a new dosage for the postoperative adjuvant therapy for [[urothelial carcinoma]].
  
 
==Also known as==
 
==Also known as==
Line 156: Line 216:
  
 
[[Category:Anal cancer medications]]
 
[[Category:Anal cancer medications]]
−
[[Category:Bladder cancer medications]]
 
 
[[Category:Carcinoma of unknown primary medications]]
 
[[Category:Carcinoma of unknown primary medications]]
 
[[Category:Cholangiocarcinoma medications]]
 
[[Category:Cholangiocarcinoma medications]]
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Latest revision as of 04:03, 1 June 2024

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General information

Class/mechanism: PD-1 receptor antibody. Nivolumab is an IgG4 kappa human monoclonal antibody which binds to the PD-1 (programmed death receptor-1) receptor and blocks its interaction with the ligands PD-L1 and PD-L2. Normally, PD-L1 and PD-L2 binding to the PD-1 receptor on T cells inhibits T-cell proliferation and cytokine production, which can impede immune system surveillance of tumors. By interfering with the binding of PD-L1 and PD-L2 to the PD-1 receptor, nivolumab can cause upregulation of the anti-tumor immune response.[1][2][3]
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Toxicity management

Diseases for which it is established (work in progress)

Diseases for which it is used

Diseases for which it was used

Patient drug information

History of changes in FDA dosing recommendations

History of changes in FDA indication

Classical Hodgkin lymphoma

Colorectal cancer

Esophageal cancer

  • 2021-05-20: Approved for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. (Based on CheckMate 577)

Esophageal adenocarcinoma

  • 2021-04-16: Approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. (Based on CheckMate 649)

Esophageal squamous cell carcinoma

  • 2020-06-10: for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. (New disease entity; based on ATTRACTION-3)
  • 2022-05-27: Approved for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) in combination with fluoropyrimidine- and platinum-based chemotherapy. (Based on CheckMate 648)
  • 2022-05-27: Approved for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) in combination with ipilimumab. (Based on CheckMate 648)

Gastric cancer

  • 2021-04-16: Approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. (Based on CheckMate 649)

Head and neck cancer

Hepatocellular carcinoma - PARTIALLY WITHDRAWN

  • 2017-09-22: Granted FDA accelerated approval for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. (New disease entity; based on CheckMate 040)
    • 2021-07-23: Accelerated approval withdrawn. (Based on CheckMate 459)
  • 2020-03-10: Accelerated approval in combination with ipilimumab for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. (Approval extended to combination therapy; based on CheckMate 040combo)

Malignant pleural mesothelioma

Melanoma

  • 2014-12-22: Accelerated approval for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab, and if BRAF V600 mutation positive, a BRAF inhibitor.(Based on CheckMate 037)
    • 2019-03-07: Converted to regular approval. (Based on CheckMate 037 & CheckMate 067)
  • 2015-09-30: Granted accelerated approval in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma. (Based on CheckMate 066 and CheckMate 067)
    • 2019-03-07: Converted to regular approval. (Based on CheckMate 037 & CheckMate 067)
  • 2017-12-20: Granted regular approval for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. (Based on CheckMate 238)
  • 2023-10-13: Approved for the adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older. (Based on CheckMate 76K)

Non-small cell lung cancer

  • 2015-10-09: Approval expanded for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. (Histology indication expanded to include nonsquamous; based on CheckMate 057)
    • Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo.
  • 2020-05-15: Approved in combination with ipilimumab as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1 (at least 1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. (Expanded to first-line setting, with PD-L1 expression requirement; based on CheckMate 227)
  • 2020-05-26: Approved in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. (PD-L1 expression requirement removed when given with chemotherapy; based on CheckMate 9LA)
  • 2022-03-04: Approved with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting. (Based on CheckMate 816)

Non-small cell lung cancer, squamous

Renal cell carcinoma

Small cell lung cancer - WITHDRAWN

  • 2018-08-16: Granted FDA accelerated approval for patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. (Based on CheckMate 032SCLC)
    • 2020-12-29: Accelerated approval withdrawn. (Based on CheckMate 331 & CheckMate 451)

Urothelial carcinoma

History of changes in EMA indication

Colorectal cancer

  • 2021-06-24: Extension of indication to include the combination of nivolumab with ipilimumab in the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (CRC) after prior fluoropyrimidine based combination chemotherapy.

Esophageal cancer

  • 2021-07-28: Extension of indication to include adjuvant treatment of adult patients with oesophageal, or gastrooesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy for OPDIVO. (Based on CheckMate 577)

Esophageal squamous cell carcinoma

  • 2020-11-20: Extension of indication to include treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) after prior fluoropyrimidine- and platinumbased chemotherapy.
  • 2022-04-01: Extension of indication to include treatment of firstline treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell PD-L1 expression at least 1% for Opdivo in combination with Yervoy.
  • 20220-04-01: Extension of indication to include in combination with fluoropyrimidine- and platinum-based combination chemotherapy the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell PD-L1 expression at least 1% for OPDIVO. (Based on CheckMate 648)

Gastric cancer

  • 2021-10-19: Extension of indication to use OPDIVO (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy, in first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) at least 5. (Based on CheckMate 649)

Head and neck cancer

Malignant pleural mesothelioma

  • 2021-06-01: Extension of indication to include first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) for combination treatment of Opdivo and Yervoy.

Melanoma

  • 2015-06-19: Initial marketing authorization as Opdivo. Opdivo as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
  • 2016-05-11: Extension of Indication to include treatment in combination with ipilimumab of advanced (unresectable or metastatic) melanoma in adults. (Based on CheckMate 067 & CheckMate 069)
  • 2018-07-30: Extension of Indication to include adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. (Based on CheckMate 238)
  • 2023-06-16: Opdivo as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.
  • 2023-06-16: Opdivo in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.
  • 2023-06-16: Opdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
  • 2023-08-21: Extension of indication to include OPDIVO for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection. (Based on CheckMate 76K)

Non-small cell lung cancer

  • 2020-11-05: Extension of indication to include first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation for combination of OPDIVO/Yervoy and chemotherapy.
  • 2023-06-26: Extension of indication to include OPDIVO in combination with platinum-based chemotherapy for neoadjuvant treatment of adult patients with resectable Stage IB-IIIA non-small cell lung cancer (NSCLC). (Based on CheckMate 816)

Non-small cell lung cancer, nonsquamous

  • 2016-04-04: Extension of Indication to include treatment as monotherapy of locally advanced or metastatic nonsquamous NSCLC after prior chemotherapy in adults. (Based on CheckMate 057)

Non-small cell lung cancer, squamous

Renal cell carcinoma

  • 2016-04-04: Extension of Indication to add treatment as monotherapy of patients with advanced renal cell carcinoma (RCC) after prior therapy in adults. (Based on CheckMate 025)
  • 2019-01-11: Extension of indication to include the combination treatment with nivolumab and ipilimumab of adult patients with intermediate/poor-risk advanced renal cell carcinoma.
  • 2021-04-13: Extension of indication to include in combination with cabozantinib for the first line treatment of advanced renal cell carcinoma for Opdivo.

Urothelial carcinoma

  • 2017-06-02: Extension of Indication to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy for OPDIVO.
  • 2022-04-01: Extension of indication for Opdivo to include as monotherapy for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression at least 1%, who are at high risk of recurrence after undergoing radical resection of MIUC.

History of changes in Health Canada indication

  • 2016-10-26: Notice of compliance with conditions for the treatment of patients with unresectable or metastatic BRAF V600 mutation-positive melanoma in previously untreated adults.
  • 2016-10-26: Notice of compliance with conditions for the treatment of patients with unresectable or metastatic melanoma in previously untreated adults when used in combination with ipilimumab.
  • 2018-03-23: Notice of compliance with conditions as a monotherapy for the treatment of adult patients with advanced (not amenable to curative therapy or local therapeutic measures) or metastatic hepatocellular carcinoma (HCC) who are intolerant to or have progressed on sorafenib therapy.
  • 2021-02-11: Notice of compliance with conditions in combination with ipilimumab. Indicated for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer after prior fluoropyrimidine-based therapy in combination with oxaliplatin or irinotecan.
  • 2022-06-27: Notice of compliance with conditions as a monotherapy for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

History of changes in PMDA indication

Carcinoma of unknown primary

Classical Hodgkin lymphoma

Colorectal cancer

  • 2020-02-21: New indication for the treatment of unresectable advanced or recurrent microsatellite instability-high (MSI-High) colorectal cancer that has progressed after cancer chemotherapy.

Esophageal cancer

  • 2020-02-21: New indication for the treatment of unresectable advanced or recurrent esophageal cancer that has progressed after cancer chemotherapy.
  • 2021-11-25: New indication and a new dosage for postoperative adjuvant therapy for esophageal cancer.
  • 2022-05-26: New indication and a new dosage for the treatment of unresectable advanced or recurrent esophageal cancer.

Gastric cancer

  • 2017-09-22: New additional indication for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after cancer chemotherapy.
  • 2021-11-25: New indication and a new dosage for the treatment of unresectable advanced or recurrent gastric cancer.

Head and neck cancer

  • 2017-03-24: New additional indication for the treatment of relapse or distant metastasis of head and neck cancer.

Mesothelioma

  • 2023-11-24: New indication and a new dosage for the treatment of malignant mesothelioma (excluding malignant pleural mesothelioma).

Malignant pleural mesothelioma

  • 2018-08-21: New indication and a new dosage for the treatment of unresectable or recurrent malignant pleural mesothelioma and melanoma that has progressed after chemotherapy.
  • 2021-05-27: New indication and a new dosage for the treatment of unresectable advanced or recurrent malignant pleural mesothelioma.

Melanoma

  • 2014-07-04: Initial approval for the treatment of unresectable malignant melanoma.
  • 2018-08-21: New indication and a new dosage for the treatment of unresectable or recurrent melanoma that has progressed after chemotherapy.

Non-small cell lung cancer

  • 2015-12-17: New additional indication and a new dosage for the treatment of unresectable advanced/relapsed non-small cell lung cancer.

Renal cell carcinoma

  • 2016-08-26: New additional indication for the treatment of unresectable or metastatic renal cell carcinoma.

Urothelial carcinoma

  • 2022-03-28: New indication and a new dosage for the postoperative adjuvant therapy for urothelial carcinoma.

Also known as

  • Code names: BMS-936558, MDX-1106, ONO-4538
  • Brand name: Opdivo

References

  1. ↑ 1.0 1.1 1.2 Nivolumab (Opdivo) package insert
  2. ↑ Nivolumab (Opdivo) package insert (locally hosted backup)
  3. ↑ Opdivo manufacturer's website
  4. ↑ Nivolumab (Opdivo) patient drug information (Chemocare)
  5. ↑ Nivolumab (Opdivo) patient drug information (UpToDate)
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