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As of Nov 14, 2026, BLA 761035 (Empliciti), held by Bristol Myers Squibb, was first approved by FDA on Nov 30, 2015, with 4 approved supplements and 0 published complete response letters.
First approved: Nov 30, 2015
Review: Priority
Supplements approved: 4
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies.
EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in
combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
