Difference between revisions of "Nivolumab (Opdivo)"

Revision as of 22:31, 20 December 2017

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]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

12/22/2014: FDA approved for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
3/4/2015: FDA approved for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
9/30/2015: Granted FDA accelerated approval in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma.
10/9/2015: FDA approval expanded for the treatment of patients with metastatic non-small cell lung cancer (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.
11/23/2015: FDA approval expanded for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy.
5/17/2016: FDA approval expanded for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin (Adcetris).
9/13/2016: FDA dosing recommendation changed to 240 mg IV every two weeks until disease progression or intolerable toxicity for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer. When combined with ipilimumab for melanoma, after completion of ipilimumab, the recommended nivolumab dose will be 240 mg every two weeks until disease progression or intolerable toxicity.
11/10/2016: FDA approved for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.
2/2/2017: Granted FDA accelerated approval for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.
8/1/2017: Granted FDA accelerated approval for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
9/22/2017: Granted FDA accelerated approval for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.
12/20/2017: Granted FDA 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.

Also known as

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

References

[insert-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)

[1]

[2]

[3]

[4]

[5]

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 ==History of changes in FDA indication==
-*12/22/2014: [http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm427716.htm FDA approved] "for the treatment of patients with unresectable or metastatic [[melanoma]] and disease progression following [[Ipilimumab (Yervoy)|ipilimumab]] and, if BRAF V600 mutation positive, a [[:Category:BRAF inhibitors|BRAF inhibitor]]."
+*12/22/2014: [http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm427716.htm FDA approved] for the treatment of patients with unresectable or metastatic [[melanoma]] and disease progression following [[Ipilimumab (Yervoy)|ipilimumab]] and, if BRAF V600 mutation positive, a [[:Category:BRAF inhibitors|BRAF inhibitor]].
-*3/4/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm436566.htm FDA approved] "for the treatment of patients with metastatic [[Non-small cell lung cancer | squamous non-small cell lung cancer (NSCLC)]] with progression on or after [[:Category:Platinum agents|platinum-based chemotherapy]]."
+*3/4/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm436566.htm FDA approved] for the treatment of patients with metastatic [[Non-small cell lung cancer | squamous non-small cell lung cancer (NSCLC)]] with progression on or after [[:Category:Platinum agents|platinum-based chemotherapy]].
-*9/30/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm465274.htm Granted FDA accelerated approval] "in combination with [[Ipilimumab (Yervoy)|ipilimumab]] for the treatment of patients with [[melanoma|BRAF V600 wild-type, unresectable or metastatic melanoma]].
+*9/30/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm465274.htm Granted FDA accelerated approval] in combination with [[Ipilimumab (Yervoy)|ipilimumab]] for the treatment of patients with [[melanoma|BRAF V600 wild-type, unresectable or metastatic melanoma]].
-*10/9/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm466576.htm FDA 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 [[:Category:Platinum agents|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."
+*10/9/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm466576.htm FDA 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 [[:Category:Platinum agents|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.
-*11/23/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm474092.htm FDA approval expanded] "for the treatment of advanced [[Renal cancer|renal cell carcinoma]] in patients who have received prior [[:Category:VEGF_inhibitors|anti-angiogenic therapy]]."
+*11/23/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm474092.htm FDA approval expanded] for the treatment of advanced [[Renal cancer|renal cell carcinoma]] in patients who have received prior [[:Category:VEGF_inhibitors|anti-angiogenic therapy]].
-*5/17/2016: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm501412.htm FDA approval expanded] "for the treatment of patients with [[Hodgkin lymphoma|classical Hodgkin lymphoma (cHL)]] that has relapsed or progressed after [[Hodgkin_lymphoma#Autologous_stem_cell_transplant|autologous hematopoietic stem cell transplantation (HSCT)]] and post-transplantation [[brentuximab vedotin (Adcetris)]]."
+*5/17/2016: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm501412.htm FDA approval expanded] for the treatment of patients with [[Hodgkin lymphoma|classical Hodgkin lymphoma (cHL)]] that has relapsed or progressed after [[Hodgkin_lymphoma#Autologous_stem_cell_transplant|autologous hematopoietic stem cell transplantation (HSCT)]] and post-transplantation [[brentuximab vedotin (Adcetris)]].
-*9/13/2016: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm520871.htm FDA dosing recommendation changed] to "240 mg IV every two weeks until disease progression or intolerable toxicity for [[Renal cancer|renal cell carcinoma]], metastatic [[melanoma]], and [[non-small cell lung cancer]]. When combined with [[Ipilimumab (Yervoy)|ipilimumab]] for [[melanoma]], after completion of ipilimumab, the recommended nivolumab dose will be 240 mg every two weeks until disease progression or intolerable toxicity."
+*9/13/2016: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm520871.htm FDA dosing recommendation changed] to 240 mg IV every two weeks until disease progression or intolerable toxicity for [[Renal cancer|renal cell carcinoma]], metastatic [[melanoma]], and [[non-small cell lung cancer]]. When combined with [[Ipilimumab (Yervoy)|ipilimumab]] for [[melanoma]], after completion of ipilimumab, the recommended nivolumab dose will be 240 mg every two weeks until disease progression or intolerable toxicity.
-*11/10/2016: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm528920.htm FDA approved] "for the treatment of patients with recurrent or metastatic [[Head and neck cancer | squamous cell carcinoma of the head and neck (SCCHN)]] with disease progression on or after a [[:Category:Platinum_agents|platinum-based therapy]]."
+*11/10/2016: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm528920.htm FDA approved] for the treatment of patients with recurrent or metastatic [[Head and neck cancer | squamous cell carcinoma of the head and neck (SCCHN)]] with disease progression on or after a [[:Category:Platinum_agents|platinum-based therapy]].
-*2/2/2017: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm539646.htm Granted FDA accelerated approval] "for treatment of patients with locally advanced or metastatic [[Bladder cancer|urothelial carcinoma]] who have disease progression during or following  [[:Category:Platinum agents|platinum-containing]] chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a  [[:Category:Platinum agents|platinum-containing]] chemotherapy."
+*2/2/2017: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm539646.htm Granted FDA accelerated approval] for treatment of patients with locally advanced or metastatic [[Bladder cancer|urothelial carcinoma]] who have disease progression during or following  [[:Category:Platinum agents|platinum-containing]] chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a  [[:Category:Platinum agents|platinum-containing]] chemotherapy.
-*8/1/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm569366.htm Granted FDA accelerated approval] "for the treatment of patients 12 years and older with [[Colon cancer|mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer]] that has progressed following treatment with a [[:Category:Fluoropyrimidines|fluoropyrimidine]], [[Oxaliplatin (Eloxatin)|oxaliplatin]], and [[Irinotecan (Camptosar)|irinotecan]]."
+*8/1/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm569366.htm Granted FDA accelerated approval] for the treatment of patients 12 years and older with [[Colon cancer|mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer]] that has progressed following treatment with a [[:Category:Fluoropyrimidines|fluoropyrimidine]], [[Oxaliplatin (Eloxatin)|oxaliplatin]], and [[Irinotecan (Camptosar)|irinotecan]].
-*9/22/2017: Granted FDA accelerated approval "for the treatment of [[Hepatobiliary_cancer|hepatocellular carcinoma (HCC)]] in patients who have been previously treated with [[Sorafenib (Nexavar)|sorafenib]]."
+*9/22/2017: Granted FDA accelerated approval for the treatment of [[Hepatobiliary_cancer|hepatocellular carcinoma (HCC)]] in patients who have been previously treated with [[Sorafenib (Nexavar)|sorafenib]].
+*12/20/2017: Granted FDA 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.
 ==Also known as==