Difference between revisions of "Ipilimumab (Yervoy)"
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==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] | + | *3/25/2011: [http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm1193237.htm FDA approved] for the treatment of unresectable or metastatic [[Melanoma | melanoma]]. |
| − | *10/28/2015: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm469944.htm FDA approved] for | + | *10/28/2015: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm469944.htm FDA approved] for adjuvant treatment of patients with cutaneous [[Melanoma | melanoma]] with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. |
*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]]. | *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]]. | ||
| − | * 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 [[ | + | *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. |
==Also known as== | ==Also known as== | ||
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[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| + | [[Category:Mutation-specific medications]] | ||
[[Category:Immunotherapeutic]] | [[Category:Immunotherapeutic]] | ||
Revision as of 16:18, 3 February 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
- 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
- 3/25/2011: FDA approved for the treatment of unresectable or metastatic melanoma.
- 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.
- 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.
- 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.
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)