Elotuzumab

Elotuzumab, sold under the brand name Empliciti, is a humanized monoclonal antibody medication used in relapsed multiple myeloma.[1] The package insert denotes its mechanism as a SLAMF7-directed (also known as CD 319) immunostimulatory antibody.[2]

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
  • AU: S4 (Prescription only)
  • US: ℞-only
  • EU: Rx-only
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
 NY (what is this?)  (verify)

Approvals and indications

Multiple myeloma

In May 2014, it was granted breakthrough therapy designation by the US Food and Drug Administration (FDA) (for multiple myeloma).[3] On November 30, 2015, FDA approved elotuzumab as a treatment for patients with multiple myeloma who have received one to three prior medications.[1] Elotuzumab was labeled for use with lenalidomide and dexamethasone. Each intravenous injection of elotuzumab should be premedicated with dexamethasone, diphenhydramine, ranitidine and acetaminophen.[2] In May 2016 the EC/EU gave a similar approval.[4]

References

  1. "Press Announcement—FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma". U.S. Food and Drug Administration. Retrieved 3 December 2015.
  2. "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.
  3. "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.
  4. BMS gets two new cancer approvals in Europe. May 2016
  • "Elotuzumab". Drug Information Portal. U.S. National Library of Medicine.


This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.