Elotuzumab
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Overview
Elotuzumab (brand name Empliciti, previously known as HuLuc63) is a humanized monoclonal antibody used in relapsed multiple myeloma.[1] The package insert denotes its mechanism as a SLAMF7-directed (also known as CD 319) immunostimulatory antibody.[2]
Approvals and indications
Multiple myeloma
In May 2014, it was granted "Breakthrough Therapy" designation by the 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
- ↑ 1.0 1.1 "Press Announcement—FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma". U.S. Food and Drug Administration. Retrieved 3 December 2015.
- ↑ 2.0 2.1 "Empliciti (elotuzumab) for Injection, for Intravenous Use. Full Prescribing Information" (PDF). Empliciti (elotuzumab) for US Healthcare Professionals. Bristol-Myers Squibb Company, Princeton, NJ 08543 USA.
- ↑ "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, NJ & North Chicago, IL: Bristol-Myers Squibb. 2014-05-19. Retrieved 2015-02-05.
- ↑ BMS gets two new cancer approvals in Europe. May 2016
External links
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