Bristol-Myers Squibb Company — Empliciti EMA EPAR public assessment report (EMEA/H/C/003967, 2016)
Bristol-Myers Squibb Company · 2016 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's public assessment report details the regulatory submission and scientific evaluation of Empliciti (elotuzumab). Bristol-Myers Squibb sought marketing authorization for Empliciti, an IgG1 monoclonal antibody targeting SLAMF7, in July 2015 for multiple myeloma treatment. In January 2016, the CHMP issued a positive opinion, recommending its use in combination with lenalidomide and dexamethasone for adult patients who have received at least one prior therapy.
Key findings — cited to the page
| Orphan medicinal product designation date | 09 August 2012 | Empliciti · EU · p.5 |
| Marketing Authorisation application submission date | 3 July 2015 | Empliciti · EU · p.5 |
| CHMP positive opinion date | 28 January 2016 | Empliciti · EU · p.6 |
| Recommended dose of Empliciti | 10 mg/kg | Empliciti · p.8 |
| Molecular mass of predominant isoform of elotuzumab | 148.1 kDa | elotuzumab · p.9 |
| Multiple myeloma accounts for | 10% | · p.6 |
| Median age at diagnosis of multiple myeloma | 65 and 70 years | · p.6 |
| Median survival of multiple myeloma (historical) | 24 to 30 months | · p.7 |
| 10-year survival rate of multiple myeloma (historical) | 3% | · p.7 |
| Median survival of multiple myeloma (recent) | 45 to 60 months | · p.7 |
| Incidence of multiple myeloma in Europe | 4.5-6/100.000/year | Europe · p.6 |
| Mortality of multiple myeloma in Europe | 4.1/100.000/year | Europe · p.6 |
Source: Bristol-Myers Squibb Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →