Back إلوتوزوماب Arabic Elotuzumab German Elotuzumab Italian エロツズマブ Japanese Elotuzumab Polish Элотузумаб Russian
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | SLAMF7 (CD319) |
| Clinical data | |
| Trade names | Empliciti |
| Other names | HuLuc63 |
| License data |
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| Pregnancy category |
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| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Bioavailability | 100% (IV) |
| Identifiers | |
| CAS Number | |
| IUPHAR/BPS | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6476H9982N1714O2016S42 |
| Molar mass | 145453.59 g·mol−1 |
  (what is this?) (verify) | |
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]
- ^ "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
- ^ "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
- ^ a b c d e f g "Elotuzumab Package Insert" (PDF). Archived (PDF) from the original on 2015-12-08.
- ^ "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.
- ^ "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.
- ^ "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.
- ^ "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.
- ^ BMS gets two new cancer approvals in Europe. May 2016
- ^ Cite error: The named reference
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