Difference between revisions of "Ipilimumab (Yervoy)"
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==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[CNS melanoma]] | *[[CNS melanoma]] | ||
| + | *[[Hepatocellular carcinoma]] | ||
*[[Melanoma]] | *[[Melanoma]] | ||
*[[Non-small cell lung cancer]] | *[[Non-small cell lung cancer]] | ||
| Line 22: | Line 23: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *3/25/2011: [http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm1193237.htm FDA approved] for the treatment of unresectable or metastatic [[Melanoma | melanoma]]. | + | ===[[:Category:Colorectal_cancers|Colorectal cancer]]=== |
| − | *10/28/2015: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm469944.htm FDA approved] for adjuvant treatment of patients with | + | *7/10/2018: Indicated 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 [[:Category:Colorectal_cancers|colorectal cancer]] that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, in combination with nivolumab. ''(New disease entity)'' |
| − | *4/16/2018: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm604685.htm FDA approved] to be used in combination with [[Nivolumab (Opdivo)]] | + | |
| − | + | ===[[Hepatocellular carcinoma]]=== | |
| + | *3/10/2020: Approved in combination with nivolumab for patients with [[hepatocellular carcinoma|hepatocellular carcinoma (HCC)]] who have been previously treated with sorafenib. ''(New disease entity)'' | ||
| + | |||
| + | ===[[Melanoma]]=== | ||
| + | *3/25/2011: [http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm1193237.htm FDA approved] for the treatment of unresectable or metastatic [[Melanoma | melanoma]]. ''(Initial approval)'' | ||
| + | *10/28/2015: [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)'' | ||
| + | |||
| + | ===[[Renal cell carcinoma]]=== | ||
| + | *4/16/2018: [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)'' | ||
==Also known as== | ==Also known as== | ||
| Line 40: | Line 49: | ||
[[Category:Anti-CTLA-4 antibodies]] | [[Category:Anti-CTLA-4 antibodies]] | ||
| + | [[Category:Hepatocellular carcinoma medications]] | ||
[[Category:Melanoma medications]] | [[Category:Melanoma medications]] | ||
[[Category:Non-small cell lung cancer medications]] | [[Category:Non-small cell lung cancer medications]] | ||
Revision as of 01:45, 12 March 2020
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]
Diseases for which it is used
- CNS melanoma
- Hepatocellular carcinoma
- Melanoma
- Non-small cell lung cancer
- Prostate cancer
- Renal cell carcinoma
- 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
- 7/10/2018: Indicated 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)
Hepatocellular carcinoma
- 3/10/2020: Approved in combination with nivolumab for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. (New disease entity)
Melanoma
- 3/25/2011: FDA approved for the treatment of unresectable or metastatic melanoma. (Initial approval)
- 10/28/2015: 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)
Renal cell carcinoma
- 4/16/2018: 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)
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)