Elotuzumab (Empliciti)

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search

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, Lexicomp, UpToDate (courtesy of Lexicomp), 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