Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 38 |
| INN | Elotuzumab |
| Status | Approved |
| Drug code(s) | BMS-901608; HuLuc63, HuLuc63-1702, PDL063 |
| Brand name | Empliciti |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | SLAMF7 |
| Indications of clinical studies | Multiple Myeloma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2006 |
| Start of Phase 2 | |
| Start of Phase 3 | June 15, 2011 |
| Date BLA/NDA submitted to FDA | June 29, 2015 |
| Year of first approval (global) | 2015 |
| Date of first US approval | November 30, 2015 |
| INN, US product name | Elotuzumab |
| US or EU approved indications | Multiple myeloma.U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI, in November 2018. Aug 2019: European Commission (EC) has approved Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy. |
| Company | AbbVie |
| Licensee/Partner | Bristol Myers Squibb |
| Comments about company or candidate | Approved in US in November 30, 2015; approved in EU in 2016 Priority review in US. EMA accepted MMA for multiple myeloma in late July 2015; accelerated assessment granted. Breakthrough Therapy desig. For multiple myleoma |
| Full address of company | North Chicago, Illinois, United States North America United States of America https://www.abbvie.com/ |
Listed as produced in NS0 cells in FDA documents
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |