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Elotuzumab: First Global Approval

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Abstract

Elotuzumab (Empliciti™) is a humanised IgG1 monoclonal antibody developed by Bristol-Myers Squibb (BMS) and AbbVie that has been approved as combination therapy with lenalidomide and dexamethasone for relapsed/refractory multiple myeloma in the US. Elotuzumab binds to the cell surface receptor signalling lymphocytic activation molecule F7 (SLAMF7), which is selectively expressed on myeloma cells and natural killer cells, leading to antibody-dependent cellular cytotoxicity and direct natural killer cell activation. In a phase III clinical trial, addition of elotuzumab to lenalidomide and dexamethasone therapy in patients with relapsed/refractory multiple myeloma was associated with a significant improvement in progression-free survival and overall response rate. This article summarizes the milestones in the development of elotuzumab leading to this first approval for relapsed/refractory multiple myeloma.

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References

  1. Tai YT, Dillon M, Song W, et al. Anti-CS1 humanized monoclonal antibody HuLuc63 inhibits myeloma cell adhesion and induces antibody-dependent cellular cytotoxicity in the bone marrow milieu. Blood. 2008;112(4):1329–37.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  2. Hsi ED, Steinle R, Balasa B, et al. CS1, a potential new therapeutic antibody target for the treatment of multiple myeloma. Clin Cancer Res. 2008;14(9):2775–84.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  3. US Food and Drug Administration. Elotuzumab [media release]. 30 Nov 2015. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm474719.htm.

  4. Bristol-Myers Squibb Company. EmplicitiTM (elotuzumab) for injection, for intravenous use: US prescribing information. 2015. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761035s000lbl.pdf. Accessed 1 Dec 2015.

  5. Bristol-Myers Squibb. European Medicines Agency validates and grants accelerated assessment of marketing authorization application for Empliciti (elotuzumab) for the treatment of multiple myeloma in patients who have received one or more prior therapies [media release]. 27 Jul 2015.

  6. Bristol-Myers Squibb Company. Bristol-Myers Squibb and PDL BioPharma enter global alliance to develop novel treatment for multiple myeloma [media release]. 19 Aug 2008.

  7. Yang WC, Lin SF. Mechanisms of drug resistance in relapse and refractory multiple myeloma. Biomed Res Int. 2015;2015:341430.

    PubMed Central  PubMed  Google Scholar 

  8. Collins SM, Bakan CE, Swartzel GD, et al. Elotuzumab directly enhances NK cell cytotoxicity against myeloma via CS1 ligation: evidence for augmented NK cell function complementing ADCC. Cancer Immunol Immunother. 2013;62(12):1841–9.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  9. van Rhee F, Szmania SM, Dillon M, et al. Combinatorial efficacy of anti-CS1 monoclonal antibody elotuzumab (HuLuc63) and bortezomib against multiple myeloma. Mol Cancer Ther. 2009;8(9):2616–24.

    Article  PubMed Central  PubMed  Google Scholar 

  10. Berdeja J, Jagannath S, Zonder J, et al. Pharmacokinetics and safety of elotuzumab in combination with lenalidomide and dexamethasone in patients with multiple myeloma and various levels of renal impairment: results of a phase 1b study. Clin Lymphoma Myeloma Leuk. 2015. doi:10.1016/j.clml.2015.12.007.

    PubMed  Google Scholar 

  11. Lonial S, Dimopoulos M, Palumbo A, et al. Elotuzumab therapy for relapsed or refractory multiple myeloma. N Engl J Med. 2015;373(7):621–31.

    Article  CAS  PubMed  Google Scholar 

  12. Richardson PG, Jagannath S, Moreau P, et al. Elotuzumab in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma: final phase 2 results from the randomised, open-label, phase 1b-2 dose-escalation study. Lancet Haematol. 2015;2(12):e516–27.

    Article  PubMed  Google Scholar 

  13. Jakubowiak A, Offidani M, Pegourie B, et al. A randomized, open-label, phase 2 study of bortezomib and dexamethasone with or without elotuzumab in patients with relapsed/refractory multiple myeloma [abstract no. S103]. Haematologica. 2015;100(Suppl 1):2.

    Google Scholar 

  14. Jakubowiak AJ, Offidani M, Pegourie B, et al. A randomized phase II study of bortezomib (Btz)/dexamethasone (dex) with or without elotuzumab (Elo) in patients (pts) with relapsed/refractory multiple myeloma (RRMM) [abstract no. 8573]. J Clin Oncol. 2015;33(15 Suppl 1).

  15. Mateos MV, Granell M, Rocafiguera AO, et al. A phase II single-arm safety study of elotuzumab in combination with thalidomide and low dose dexamethasone in patients with relapsed and/or refractory multiple myeloma [abstract no. P959]. Haematologica. 2014;99(Suppl 1).

  16. Jakubowiak AJ, Benson DM, Bensinger W, et al. Phase I trial of anti-CS1 monoclonal antibody elotuzumab in combination with bortezomib in the treatment of relapsed/refractory multiple myeloma. J Clin Oncol. 2012;30(16):1960–5.

    Article  CAS  PubMed  Google Scholar 

  17. Usmani SZ, Sexton R, Ailawadhi S, et al. SWOG 1211: initial report on phase I trial of RVD-elotuzumab for newly diagnosed high risk multiple myeloma (HRMM) [abstract no. 4762 plus poster]. In: 56th annual meeting and exposition of the American Society of Hematology; 2014; San Francisco, CA.

  18. Usmani SZ, Sexton R, Ailawadhi S, et al. Phase I safety data of lenalidomide, bortezomib, dexamethasone, and elotuzumab as induction therapy for newly diagnosed symptomatic multiple myeloma: SWOG S1211. Blood Cancer J. 2015;5:e334.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  19. Usmani SZ, Hoering A, Sexton R, et al. SWOG 1211: a randomized phase I/II study of optimal induction therapy for newly diagnosed high-risk multiple myeloma (HRMM) [abstract no. TPS8624]. J Clin Oncol. 2014;32(15 Suppl 1).

  20. Dimopoulos M, Facon T, Richardson P, et al. ELOQUENT-1: a phase III, randomized, open-label trial of lenalidomide/dexamethasone with or without elotuzumab in subjects with previously untreated multiple myeloma (CA204-006) [abstract no. TPS8113]. J Clin Oncol. 2012;30(15 Suppl).

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  1. Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Anthony Markham

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  1. Anthony Markham
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Correspondence to Anthony Markham.

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The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Anthony Markham is a contracted employee of Adis, Springer SBM.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Markham, A. Elotuzumab: First Global Approval. Drugs 76, 397–403 (2016). https://doi.org/10.1007/s40265-016-0540-0

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