Difference between revisions of "Ipilimumab (Yervoy)"
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<br>Extravasation: no information | <br>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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> | ||
| + | |||
| + | ==Toxicity management== | ||
*[http://www.yervoy.com/hcp/rems.aspx YERVOY Risk Evaluation and Mitigation Strategy (REMS) Site]<ref>[http://www.yervoy.com/hcp/rems.aspx YERVOY Risk Evaluation and Mitigation Strategy (REMS) Site]</ref> | *[http://www.yervoy.com/hcp/rems.aspx YERVOY Risk Evaluation and Mitigation Strategy (REMS) Site]<ref>[http://www.yervoy.com/hcp/rems.aspx YERVOY Risk Evaluation and Mitigation Strategy (REMS) Site]</ref> | ||
| + | *[[Immunotherapy toxicity management]] | ||
| − | + | ==Diseases for which it is established ''(work in progress)''== | |
| + | *[[Hepatocellular carcinoma]] | ||
| + | *[[Melanoma]] | ||
| + | **[[Uveal melanoma]] | ||
| + | *[[Malignant pleural mesothelioma]] | ||
| + | *[[Non-small cell lung cancer]] | ||
| + | **[[Non-small cell lung cancer, nonsquamous]] | ||
| + | **[[Non-small cell lung cancer, squamous]] | ||
| + | *[[Renal cell carcinoma]] | ||
| + | **[[Clear cell renal cell carcinoma]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[CNS melanoma]] | *[[CNS melanoma]] | ||
| − | *[[ | + | *[[Colorectal cancer]] |
| − | + | *[[Esophageal squamous cell carcinoma]] | |
| − | |||
| − | *[[ | ||
*[[Prostate cancer]] | *[[Prostate cancer]] | ||
| − | |||
*[[Small cell lung cancer]] | *[[Small cell lung cancer]] | ||
==Patient drug information== | ==Patient drug information== | ||
*[http://packageinserts.bms.com/pi/pi_yervoy.pdf Ipilimumab (Yervoy) package insert]<ref name="insert"></ref> | *[http://packageinserts.bms.com/pi/pi_yervoy.pdf Ipilimumab (Yervoy) package insert]<ref name="insert"></ref> | ||
| − | *[https://chemocare.com/ | + | *[https://chemocare.com/druginfo/ipilimumab.aspx Ipilimumab (Yervoy) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/ipilimumab.aspx Ipilimumab (Yervoy) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/ipilimumab-patient-drug-information Ipilimumab (Yervoy) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/ipilimumab-patient-drug-information Ipilimumab (Yervoy) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/ipilimumab-patient-drug-information Ipilimumab (Yervoy) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/ipilimumab-patient-drug-information Ipilimumab (Yervoy) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | ===[[ | + | ===[[Colorectal cancer]]=== |
| − | * | + | *2018-07-10: Accelerated approval for treatment of adult and pediatric patients 12 years of age and older with [[Biomarkers#MSI-H|microsatellite instability-high (MSI-H)]] or [[Biomarkers#dMMR|mismatch repair deficient (dMMR)]] metastatic [[colorectal cancer]] that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, in combination with nivolumab. ''(New disease entity; based on CheckMate 142)'' |
===[[Hepatocellular carcinoma]]=== | ===[[Hepatocellular carcinoma]]=== | ||
| − | * | + | *2020-03-10: Accelerated approval in combination with nivolumab for patients with [[hepatocellular carcinoma|hepatocellular carcinoma (HCC)]] who have been previously treated with sorafenib. ''(Based on CheckMate 040<sub>combo</sub>)'' |
===[[Melanoma]]=== | ===[[Melanoma]]=== | ||
| − | * | + | *2011-03-25: [http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm1193237.htm FDA approved] for the treatment of unresectable or metastatic [[Melanoma | melanoma]]. ''(Initial approval; based on MDX010-20)'' |
| − | *10 | + | *2015-10-28: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm469944.htm FDA approved] for adjuvant treatment of patients with [[Melanoma|cutaneous melanoma]] with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. ''(Approval extended to adjuvant setting; based on EORTC 18071)'' |
| − | ===[[ | + | ===[[Malignant pleural mesothelioma]]=== |
| − | *10 | + | *2020-10-02: Approved in combination with [[Nivolumab (Opdivo)|nivolumab]] as first-line treatment for adult patients with unresectable [[malignant pleural mesothelioma]]. ''(New disease entity; based on CheckMate 743)'' |
===[[Non-small cell lung cancer]]=== | ===[[Non-small cell lung cancer]]=== | ||
| − | * | + | *2020-05-15: Approved in combination with [[Nivolumab (Opdivo)|nivolumab]] 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. ''(New disease entity; based on CheckMate 227)'' |
| − | * | + | *2020-05-26: Approved in combination with [[Nivolumab (Opdivo)|nivolumab]] 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)'' |
===[[Renal cell carcinoma]]=== | ===[[Renal cell carcinoma]]=== | ||
| − | * | + | *2018-04-16: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm604685.htm FDA approved] to be used in combination with [[Nivolumab (Opdivo)]] for the treatment of intermediate or poor risk, previously untreated [[Renal cell carcinoma|advanced renal cell carcinoma]]. ''(New disease entity; based on CheckMate 214)'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | * | + | *2011-07-13: Initial marketing authorization as Yervoy. Yervoy is indicated for the treatment of advanced (unresectable or metastatic) [[melanoma]] in adults who have received prior therapy. ''(Based on MDX010-20)'' |
| + | *2013-10-31: Extension of indication of Yervoy for the treatment of previously untreated adult patients with advanced (unresectable or metastatic) [[melanoma]]. | ||
| + | *2018-01-18: Extension of indication to include the treatment of advanced (unresectable or metastatic) [[melanoma]] in adults and adolescents 12 years of age and older. | ||
| + | *2018-05-31: Extension of indication to include the treatment of advanced (unresectable or metastatic) [[melanoma]] in adults in combination with nivolumab for Yervoy. | ||
| + | *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]]. | ||
| + | *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. | ||
| + | *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. | ||
| + | *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. | ||
| + | *2022-04-01: Extension of indication to include 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 in combination with Yervoy. | ||
| + | *2023-05-23: Extension of indication to include in combination with nivolumab the treatment of adolescents (12 years of age and older) for advanced (unresectable or metastatic) [[melanoma]]. ''(Based on NCI-2014-01222)'' | ||
| + | |||
| + | ==History of changes in Health Canada indication== | ||
| + | ===[[Colorectal cancer]]=== | ||
| + | *2022-03-03: New indication in combination with nivolumab for Microsatellite Instability-High (MSI-H)/ Mismatch Repair Deficient (dMMR) Metastatic [[colorectal cancer]]. | ||
| + | ===[[Melanoma]]=== | ||
| + | *2012-02-01: Initial notice of compliance for the treatment of unresectable or metastatic [[melanoma]] in patients who have failed or do not tolerate other systemic therapy for advanced disease. | ||
| + | *2014-09-10: Revised indication for the treatment of unresectable or metastatic [[melanoma]]. | ||
| + | *2017-04-13: New indication in combination with Opdivo (nivolumab) for the treatment of unresectable or metastatic [[melanoma]] in previously untreated adults. | ||
| + | *2022-03-03: New reduction of indication for Unresectable or Metastatic [[Melanoma]] (unclear details). | ||
| + | ===[[Malignant pleural mesothelioma]]=== | ||
| + | *2022-03-03: New indication in combination with nivolumab for unresectable [[Malignant pleural mesothelioma|Malignant Pleural Mesothelioma (MPM)]]. | ||
| + | ===[[Renal cell carcinoma]]=== | ||
| + | *2018-12-04: New indication in combination with Opdivo (nivolumab) for the treatment of adult patients with intermediate/poor-risk advanced or metastatic [[renal cell carcinoma]]. | ||
| + | ===[[Non-small cell lung cancer]]=== | ||
| + | *2022-03-03: New indication in combination with nivolumab for metastatic [[Non-small cell lung cancer|Non-Small Cell Lung Cancer (NSCLC)]]. | ||
| + | |||
| + | ==History of changes in PMDA indication== | ||
| + | ===[[Colorectal cancer]]=== | ||
| + | *2020-09-25: 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]]=== | ||
| + | *2022-05-26: New indication and a new dosage for the treatment of unresectable advanced or recurrent [[esophageal cancer]]. | ||
| + | ===[[Malignant pleural mesothelioma]]=== | ||
| + | *2021-05-27: New indication and a new dosage for the treatment of unresectable advanced or recurrent [[malignant pleural mesothelioma]]. | ||
| + | ===[[Melanoma]]=== | ||
| + | *2015-07-03: Initial approval for the treatment of unresectable [[melanoma]]. | ||
| + | ===[[Non-small cell lung cancer]]=== | ||
| + | *2020-11-27: New indication and a new dosage for the treatment of unresectable advanced or recurrent [[non-small cell lung cancer]]. | ||
| + | ===[[Renal cell carcinoma]]=== | ||
| + | *2018-08-21: New indication and a new dosage for the treatment of unresectable or metastatic [[renal cell carcinoma]]. | ||
==Also known as== | ==Also known as== | ||
| Line 61: | Line 109: | ||
[[Category:Anti-CTLA-4 antibodies]] | [[Category:Anti-CTLA-4 antibodies]] | ||
| + | [[Category:Colorectal cancer medications]] | ||
| + | [[Category:Esophageal squamous cell carcinoma medications]] | ||
[[Category:Hepatocellular carcinoma medications]] | [[Category:Hepatocellular carcinoma medications]] | ||
[[Category:Melanoma medications]] | [[Category:Melanoma medications]] | ||
| − | [[Category: | + | [[Category:Malignant pleural mesothelioma medications]] |
[[Category:Non-small cell lung cancer medications]] | [[Category:Non-small cell lung cancer medications]] | ||
| + | [[Category:Non-small cell lung cancer, nonsquamous medications]] | ||
| + | [[Category:Non-small cell lung cancer, squamous medications]] | ||
[[Category:Prostate cancer medications]] | [[Category:Prostate cancer medications]] | ||
[[Category:Renal cell carcinoma medications]] | [[Category:Renal cell carcinoma medications]] | ||
| + | [[Category:Clear cell renal cell carcinoma medications]] | ||
| + | [[Category:Small cell lung cancer medications]] | ||
| + | [[Category:Uveal melanoma medications]] | ||
[[Category:EMA approved in 2011]] | [[Category:EMA approved in 2011]] | ||
[[Category:FDA approved in 2011]] | [[Category:FDA approved in 2011]] | ||
| − | [[Category:PMDA approved | + | [[Category:Health Canada approved in 2012]] |
| + | [[Category:PMDA approved in 2015]] | ||
Latest revision as of 14:12, 9 February 2024
General information
Class/mechanism: Anti-CTLA-4 antibody. CTLA-4 is a negative regulator of T-cell activation and ipilimumab interferes with the ability of CTLA-4 to interact with its ligands CD80/CD86. CTLA-4 blockade results in T-cell activation and proliferation, and it is suspected that its anti-neoplastic activity may be due to T-cell mediated anti-tumor immune responses.[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)
- Hepatocellular carcinoma
- Melanoma
- Malignant pleural mesothelioma
- Non-small cell lung cancer
- Renal cell carcinoma
Diseases for which it is used
- CNS melanoma
- Colorectal cancer
- Esophageal squamous cell carcinoma
- Prostate cancer
- Small cell lung cancer
Patient drug information
- Ipilimumab (Yervoy) package insert[1]
- Ipilimumab (Yervoy) patient drug information (Chemocare)[5]
- Ipilimumab (Yervoy) patient drug information (UpToDate)[6]
History of changes in FDA indication
Colorectal cancer
- 2018-07-10: Accelerated approval for treatment of adult and pediatric patients 12 years of age and older 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, in combination with nivolumab. (New disease entity; based on CheckMate 142)
Hepatocellular carcinoma
- 2020-03-10: Accelerated approval in combination with nivolumab for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. (Based on CheckMate 040combo)
Melanoma
- 2011-03-25: FDA approved for the treatment of unresectable or metastatic melanoma. (Initial approval; based on MDX010-20)
- 2015-10-28: FDA approved for adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. (Approval extended to adjuvant setting; based on EORTC 18071)
Malignant pleural mesothelioma
- 2020-10-02: Approved in combination with nivolumab as first-line treatment for adult patients with unresectable malignant pleural mesothelioma. (New disease entity; based on CheckMate 743)
Non-small cell lung cancer
- 2020-05-15: Approved in combination with nivolumab 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. (New disease entity; based on CheckMate 227)
- 2020-05-26: Approved in combination with nivolumab 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)
Renal cell carcinoma
- 2018-04-16: FDA approved to be used in combination with Nivolumab (Opdivo) for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. (New disease entity; based on CheckMate 214)
History of changes in EMA indication
- 2011-07-13: Initial marketing authorization as Yervoy. Yervoy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy. (Based on MDX010-20)
- 2013-10-31: Extension of indication of Yervoy for the treatment of previously untreated adult patients with advanced (unresectable or metastatic) melanoma.
- 2018-01-18: Extension of indication to include the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.
- 2018-05-31: Extension of indication to include the treatment of advanced (unresectable or metastatic) melanoma in adults in combination with nivolumab for Yervoy.
- 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.
- 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.
- 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.
- 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.
- 2022-04-01: Extension of indication to include 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 in combination with Yervoy.
- 2023-05-23: Extension of indication to include in combination with nivolumab the treatment of adolescents (12 years of age and older) for advanced (unresectable or metastatic) melanoma. (Based on NCI-2014-01222)
History of changes in Health Canada indication
Colorectal cancer
- 2022-03-03: New indication in combination with nivolumab for Microsatellite Instability-High (MSI-H)/ Mismatch Repair Deficient (dMMR) Metastatic colorectal cancer.
Melanoma
- 2012-02-01: Initial notice of compliance for the treatment of unresectable or metastatic melanoma in patients who have failed or do not tolerate other systemic therapy for advanced disease.
- 2014-09-10: Revised indication for the treatment of unresectable or metastatic melanoma.
- 2017-04-13: New indication in combination with Opdivo (nivolumab) for the treatment of unresectable or metastatic melanoma in previously untreated adults.
- 2022-03-03: New reduction of indication for Unresectable or Metastatic Melanoma (unclear details).
Malignant pleural mesothelioma
- 2022-03-03: New indication in combination with nivolumab for unresectable Malignant Pleural Mesothelioma (MPM).
Renal cell carcinoma
- 2018-12-04: New indication in combination with Opdivo (nivolumab) for the treatment of adult patients with intermediate/poor-risk advanced or metastatic renal cell carcinoma.
Non-small cell lung cancer
- 2022-03-03: New indication in combination with nivolumab for metastatic Non-Small Cell Lung Cancer (NSCLC).
History of changes in PMDA indication
Colorectal cancer
- 2020-09-25: 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
- 2022-05-26: New indication and a new dosage for the treatment of unresectable advanced or recurrent esophageal cancer.
Malignant pleural mesothelioma
- 2021-05-27: New indication and a new dosage for the treatment of unresectable advanced or recurrent malignant pleural mesothelioma.
Melanoma
- 2015-07-03: Initial approval for the treatment of unresectable melanoma.
Non-small cell lung cancer
- 2020-11-27: New indication and a new dosage for the treatment of unresectable advanced or recurrent non-small cell lung cancer.
Renal cell carcinoma
- 2018-08-21: New indication and a new dosage for the treatment of unresectable or metastatic renal cell carcinoma.
Also known as
- Code names: BMS-734016, MDX-010
- Brand name: Yervoy
References
- ↑ 1.0 1.1 1.2 Ipilimumab (Yervoy) package insert
- ↑ Ipilimumab (Yervoy) package insert (locally hosted backup)
- ↑ Yervoy manufacturer's website
- ↑ YERVOY Risk Evaluation and Mitigation Strategy (REMS) Site
- ↑ Ipilimumab (Yervoy) patient drug information (Chemocare)
- ↑ Ipilimumab (Yervoy) patient drug information (UpToDate)
Categories:
- Drugs
- Intravenous medications
- Mutation-specific medications
- Protein expression-specific medications
- Anti-CTLA-4 antibodies
- Colorectal cancer medications
- Esophageal squamous cell carcinoma medications
- Hepatocellular carcinoma medications
- Melanoma medications
- Malignant pleural mesothelioma medications
- Non-small cell lung cancer medications
- Non-small cell lung cancer, nonsquamous medications
- Non-small cell lung cancer, squamous medications
- Prostate cancer medications
- Renal cell carcinoma medications
- Clear cell renal cell carcinoma medications
- Small cell lung cancer medications
- Uveal melanoma medications
- EMA approved in 2011
- FDA approved in 2011
- Health Canada approved in 2012
- PMDA approved in 2015