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Empliciti Approval History

FDA Approved: Yes (First approved November 30, 2015)
Brand name: Empliciti
Generic name: elotuzumab
Dosage form: Injection
Company: Bristol-Myers Squibb Company and AbbVie
Treatment for: Multiple Myeloma

Empliciti (elotuzumab) is a Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

Development History and FDA Approval Process for Empliciti

DateArticle
Nov 30, 2015Approval FDA Approves Empliciti (elotuzumab) for Multiple Myeloma
Sep  1, 2015FDA Accepts for Priority Review the BLA for Empliciti (elotuzumab) for the Treatment of Multiple Myeloma
Jun  2, 2015Adding Investigational Agent Elotuzumab to Standard Treatment for Multiple Myeloma Significantly Reduced the Risk of Disease Progression, According to New Phase III Data
May 19, 2014BMS and AbbVie Receive U.S. FDA Breakthrough Therapy Designation for Elotuzumab for Multiple Myeloma
Jun 17, 2013Bristol-Myers Squibb and AbbVie Announce Progression-Free Survival Data from Phase 2 Open-Label Study of Investigational Agent Elotuzumab
Dec  7, 2010Encouraging Phase 2 Interim Data for Elotuzumab in Relapsed Multiple Myeloma Presented at 52nd American Society of Hematology Annual Meeting
Dec  7, 2009Facet Biotech and Bristol-Myers Squibb Report Promising Phase I/II Interim Data for Elotuzumab in Patients with Relapsed Multiple Myeloma

Further information

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