Difference between revisions of "Elotuzumab (Empliciti)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Humanized IgG1 monoclonal antibody which targets SLAMF7 (Signaling Lymphocytic Activation Molecule Family member 7). | + | Class/mechanism: Humanized IgG1 monoclonal antibody which targets SLAMF7 (Signaling Lymphocytic Activation Molecule Family member 7). SLAMF7 is a protein which is expressed on myeloma cells, Natural Killer cells, plasma cells, and expressed at lower levels on certain immune cell subsets of differentiated cells. Elotuzumab facilitates antibody-dependent cellular cytotoxicity (ADCC) between myeloma cells and Natural Killer cells. The antigen target of elotuzumab may also be known as CS1 (CD2 subset 1, CRACC, SLAMF7).<ref name=insert>[http://packageinserts.bms.com/pi/pi_empliciti.pdf Elotuzumab (Empliciti) package insert]</ref><ref>[[:File:Elotuzumab.pdf|Elotuzumab (Empliciti) package insert (locally hosted backup)]]</ref><ref>[http://www.empliciti.com/ Empliciti manufacturer's website]</ref><ref>[https://www.cancer.gov/publications/dictionaries/cancer-drug?CdrID=532249 Elotuzumab entry at the NCI Drug Dictionary]</ref> |
<ref>[http://www.themmrf.org/living-with-multiple-myeloma/newly-diagnosed-patients/what-is-multiple-myeloma/elotuzumab-huluc63.html Elotuzumab (HuLuc63) @ the Multiple Myeloma Research Foundation]</ref> | <ref>[http://www.themmrf.org/living-with-multiple-myeloma/newly-diagnosed-patients/what-is-multiple-myeloma/elotuzumab-huluc63.html Elotuzumab (HuLuc63) @ the Multiple Myeloma Research Foundation]</ref> | ||
<br>Route: IV | <br>Route: IV | ||
<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 | + | 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, UpToDate Lexidrug, or the package insert.<ref name=insert></ref> |
==Diseases for which it is established== | ==Diseases for which it is established== | ||
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==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2016-05-11: Initial authorization | *2016-05-11: Initial authorization | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2016-06-21: Initial notice of compliance | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2016-09-28: New approval for the treatment of relapsed or refractory [[multiple myeloma]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code names:''' BMS-901608, HuLuc63 | + | *'''Code names:''' BMS-901608, HuLuc63, PDL-063 |
*'''Generic name:''' anti-CS1 monoclonal antibody HuLuc63 | *'''Generic name:''' anti-CS1 monoclonal antibody HuLuc63 | ||
*'''Brand name:''' Empliciti | *'''Brand name:''' Empliciti | ||
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[[Category:FDA approved in 2015]] | [[Category:FDA approved in 2015]] | ||
[[Category:EMA approved in 2016]] | [[Category:EMA approved in 2016]] | ||
| − | [[Category:PMDA approved | + | [[Category:Health Canada approved in 2016]] |
| + | [[Category:PMDA approved in 2016]] | ||
Latest revision as of 00:15, 6 July 2024
General information
Class/mechanism: Humanized IgG1 monoclonal antibody which targets SLAMF7 (Signaling Lymphocytic Activation Molecule Family member 7). SLAMF7 is a protein which is expressed on myeloma cells, Natural Killer cells, plasma cells, and expressed at lower levels on certain immune cell subsets of differentiated cells. Elotuzumab facilitates antibody-dependent cellular cytotoxicity (ADCC) between myeloma cells and Natural Killer cells. The antigen target of elotuzumab may also be known as CS1 (CD2 subset 1, CRACC, SLAMF7).[1][2][3][4]
[5]
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, UpToDate Lexidrug, or the package insert.[1]
Diseases for which it is established
Patient drug information
History of changes in FDA indication
- 2015-11-30: FDA approved to be used in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. (Based on ELOQUENT-2)
- 2018-11-06: Approved in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. (Based on ELOQUENT-3)
History of changes in EMA indication
- 2016-05-11: Initial authorization
History of changes in Health Canada indication
- 2016-06-21: Initial notice of compliance
History of changes in PMDA indication
- 2016-09-28: New approval for the treatment of relapsed or refractory multiple myeloma.
Also known as
- Code names: BMS-901608, HuLuc63, PDL-063
- Generic name: anti-CS1 monoclonal antibody HuLuc63
- Brand name: Empliciti