Elotuzumab

Elotuzumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetSLAMF7 (CD319)
Clinical data
Trade namesEmpliciti
Other namesHuLuc63
License data
Pregnancy
category
  • AU: C
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability100% (IV)
Identifiers
CAS Number
IUPHAR/BPS
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6476H9982N1714O2016S42
Molar mass145453.59 g·mol−1
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Elotuzumab, sold under the brand name Empliciti, is a humanized IgG1 monoclonal antibody medication used in combination with lenalidomide and dexamethasone, for adults that have received 1 to 3 prior therapies for the treatment of multiple myeloma.[3] It is also indicated for adult patients in combination with pomalidomide and dexamethasone, who have received 2 prior therapies including lenalidomide and a protease inhibitor.[3] Administration of elotuzumab is done intravenously.[3] Each intravenous injection of elotuzumab should be premedicated with dexamethasone, diphenhydramine, ranitidine and acetaminophen.[4] It is being developed by Bristol Myers Squibb and AbbVie.[5]

Common side effects of elotuzumab with lenalidomide and dexamethasone includes fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, and pneumonia.[3] The most common side effects of elotuzumab with pomalidomide and dexamethasone includes constipation and hyperglycemia.[3] There is no available information for the use of elotuzumab in pregnant women.[3]

Elotuzumab is an immunostimulatory antibody that targets the Signaling Lymphocytic Activation Molecule Family member 7 (SLAMF7) through two mechanisms.[3]

In May 2014, it was granted breakthrough therapy designation by the US Food and Drug Administration (FDA) (for multiple myeloma).[6] The initial FDA approval of elotuzumab in 2015 in combination with lenalidomide and dexamethasone was carried out through the results illustrated in the ELOQUENT 2 study.[7] In May 2016 the EC/EU gave a similar approval.[8] Furthermore, the results of the ELOQUENT 3 study led to the FDA approval of elotuzumab in combination with pomalidomide and dexamethasone in 2018.[9]

  1. ^ "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  2. ^ "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
  3. ^ a b c d e f g "Elotuzumab Package Insert" (PDF). Archived (PDF) from the original on 2015-12-08.
  4. ^ "Empliciti (elotuzumab) for Injection, for Intravenous Use. Full Prescribing Information" (PDF). Empliciti (elotuzumab) for US Healthcare Professionals. Princeton, New Jersey: Bristol-Myers Squibb Company. Archived from the original (PDF) on 2015-12-08.
  5. ^ "Bristol Myers Squibb Reports Primary Results of ELOQUENT-1 Study Evaluating Empliciti (elotuzumab) Plus Revlimid (lenalidomide) and Dexamethasone in Patients with Newly Diagnosed, Untreated Multiple Myeloma". news.bms.com. Retrieved 2021-03-18.
  6. ^ "Bristol-Myers Squibb and AbbVie Receive U.S. FDA Breakthrough Therapy Designation for Elotuzumab, an Investigational Humanized Monoclonal Antibody for Multiple Myeloma" (Press release). Princeton, New Jersey and North Chicago, Illinois: Bristol-Myers Squibb. 2014-05-19. Retrieved 2015-02-05.
  7. ^ "Bristol-Myers Squibb and AbbVie Receive FDA Approval of Empliciti™ (elotuzumab) for the Treatment of Patients with Multiple Myeloma Who Have Received One to Three Prior Therapies". news.bms.com. Retrieved 2021-03-18.
  8. ^ BMS gets two new cancer approvals in Europe. May 2016
  9. ^ Cite error: The named reference news.bms.com was invoked but never defined (see the help page).