Difference between revisions of "Elotuzumab (Empliciti)"

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==General information==
 
==General information==
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Class/mechanism from [http://www.cancer.gov/publications/dictionaries/cancer-drug?CdrID=532249 NCI Drug Dictionary]: A humanized monoclonal antibody directed against the human CS1 (CD2 subset 1, CRACC, SLAMF7) antigen with potential antineoplastic activity. Elotuzumab binds to the CS1 antigen, which may trigger antibody-dependent cellular cytotoxicity (ADCC) in cells expressing CS1.<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>
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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>
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<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
  
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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 package insert.
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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>
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==Preliminary data==
 
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===[[Multiple myeloma]]===
 
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# Lonial S, Vij R, Harousseau JL, Facon T, Moreau P, Mazumder A, Kaufman JL, Leleu X, Tsao LC, Westland C, Singhal AK, Jagannath S. Elotuzumab in combination with lenalidomide and low-dose dexamethasone in relapsed or refractory multiple myeloma. J Clin Oncol. 2012 Jun 1;30(16):1953-9. Epub 2012 Apr 30. [http://www.ncbi.nlm.nih.gov/pubmed/22547589 PubMed]
 
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# '''Abstract:''' Richardson, Paul G., Jagannath, Sundar, Moreau, Philippe, Jakubowiak, Andrzej, Raab, Marc S, Facon, Thierry, Vij, Ravi, White, Darrell J., Reece, Donna, Benboubker, Lotfi, Zonder, Jeffrey A., Deng, Wei, Kroog, Glenn, Singhal, Anil K, Lonial, Sagar. A Phase 2 Study of Elotuzumab (Elo) in Combination with Lenalidomide and Low-Dose Dexamethasone (Ld) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (R/R MM): Updated Results. ASH Annual Meeting Abstracts 2012 120: 202
 
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# Lonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, Walter-Croneck A, Moreau P, Mateos MV, Magen H, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Röllig C, Einsele H, Wu KL, Singhal A, San-Miguel J, Matsumoto M, Katz J, Bleickardt E, Poulart V, Anderson KC, Richardson P; ELOQUENT-2 Investigators. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2015 Aug 13;373(7):621-31. Epub 2015 Jun 2. [http://www.nejm.org/doi/full/10.1056/NEJMoa1505654 link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/26035255 PubMed]
 
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==Dexamethasone, Elotuzumab & Lenalidomide {{#subobject:b79daa |Regimen=1}}==
 
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===Regimen, Richardson et al. 2012 {{#subobject:f2d044 |Variant=1}}===
 
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border-style:solid;">Phase II</span>
 
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''Note: the dose of elotuzumab reported here is that used in the ongoing phase III trials.''
 
  
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*[[Dexamethasone (Decadron)]] 40 mg PO once per week or 28 mg PO plus 8 mg IV on [[Elotuzumab (HuLuc63)]] dosing days
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==Diseases for which it is established==
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*[[Elotuzumab (HuLuc63)]] 20 mg/kg IV once on days 1, 8, 15, 22 of cycles 1 & 2, then once on days 1 & 15 of subsequent cycles
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*[[Multiple myeloma]]
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*[[Lenalidomide (Revlimid)]] 25 mg PO once per day on days 1 to 21
 
  
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'''28-day cycles'''
 
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===References===
 
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# '''Abstract:''' Richardson, Paul G., Jagannath, Sundar, Moreau, Philippe, Jakubowiak, Andrzej, Raab, Marc S, Facon, Thierry, Vij, Ravi, White, Darrell J., Reece, Donna, Benboubker, Lotfi, Zonder, Jeffrey A., Deng, Wei, Kroog, Glenn, Singhal, Anil K, Lonial, Sagar. A Phase 2 Study of Elotuzumab (Elo) in Combination with Lenalidomide and Low-Dose Dexamethasone (Ld) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (R/R MM): Updated Results. ASH Annual Meeting Abstracts 2012 120: 202
 
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==Patient drug information==
 
==Patient drug information==
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No information available.
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*[http://packageinserts.bms.com/pi/pi_empliciti.pdf Elotuzumab (Empliciti) package insert]<ref name=insert></ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
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* 5/19/2014: Granted FDA [http://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm Breakthrough Therapy designation] "for use in combination with [[Lenalidomide (Revlimid) | lenalidomide]] and [[Dexamethasone (Decadron) | dexamethasone]] for the treatment of [[Multiple myeloma | multiple myeloma]] in patients who have received one or more prior therapies."
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*2015-11-30: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm474719.htm FDA approved] to be used in combination with [[Lenalidomide (Revlimid) | lenalidomide]] and [[Dexamethasone (Decadron) | dexamethasone]] for the treatment of patients with [[Multiple myeloma | multiple myeloma]] who have received one to three prior therapies. ''(Based on ELOQUENT-2)''
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*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)''
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==History of changes in EMA indication==
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*2016-05-11: Initial authorization
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==History of changes in Health Canada indication==
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*2016-06-21: Initial notice of compliance
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==History of changes in PMDA indication==
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*2016-09-28: New approval for the treatment of relapsed or refractory [[multiple myeloma]].
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==Also known as==
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*'''Code names:''' BMS-901608, HuLuc63, PDL-063
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*'''Generic name:''' anti-CS1 monoclonal antibody HuLuc63
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*'''Brand name:''' Empliciti
  
 
==References==
 
==References==
 
<references/>
 
<references/>
  
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[[Category:Drug index]]
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[[Category:Drugs]]
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[[Category:Chemotherapy]]
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[[Category:Intravenous medications]]
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[[Category:Intravenous chemotherapy]]
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[[Category:Antibody medications]]
 
 
[[Category:Anti-SLAMF7 antibodies]]
 
[[Category:Anti-SLAMF7 antibodies]]
  
 
[[Category:Multiple myeloma medications]]
 
[[Category:Multiple myeloma medications]]
  
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[[Category:Investigational]]
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[[Category:FDA approved in 2015]]
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[[Category:EMA approved in 2016]]
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[[Category:Health Canada approved in 2016]]
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[[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

References

  1. ↑ 1.0 1.1 1.2 Elotuzumab (Empliciti) package insert
  2. ↑ Elotuzumab (Empliciti) package insert (locally hosted backup)
  3. ↑ Empliciti manufacturer's website
  4. ↑ Elotuzumab entry at the NCI Drug Dictionary
  5. ↑ Elotuzumab (HuLuc63) @ the Multiple Myeloma Research Foundation
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