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32817811000001108

Refrigerated Storage

EmplicitiBristol-Myers Squibb Pharmaceuticals Ltd

Bristol-Myers Squibb Pharmaceuticals Ltd
Empliciti
Powder for concentrate for solution for infusion (300mg and 400mg)

Contact Bristol-Myers Squibb Pharmaceuticals Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

24 September 2021
London MI Service

New Medicines

EmplicitiMultiple myeloma (MM), first-line in combination with lenalidomide

Information

Empliciti
Licence extension / variation
Bristol-Myers Squibb
Bristol-Myers Squibb

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Yes
Yes
Mar 20Eloquent-1 study did not meet its PFS primary endpoint. Regulatory filing will not be pursued in the EU. No longer listed in AbbVie pipeline; assume all development stopped [11,12].

Category

Humanized anti-CS1 monoclonal IgG1 antibody
The incidence of MM in the UK is about 5 per 100,000 population. Median survival of patients with stage II and III disease is 45 and 29 months, respectively.
Multiple myeloma (MM), first-line in combination with lenalidomide
Intravenous

Further information

Yes

Trial or other data

Mar 20Topline data from the PIII ELOQUENT-1 study (NCT01335399) show that the addition of Empliciti to lenalidomide in transplant-ineligible pts with MM failed to acheive a statistically significant improvement in PFS vs. std of care. Overall survival data are yet to be announced and no new safety signals were observed in the trial. [10]

Evidence based evaluations