BRISTOL MYERS SQUIBB — Empliciti FDA Summary Review (NDA/BLA 761035, 2015)
Bristol-Myers Squibb Company · 2015 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
The FDA review of Bristol-Myers Squibb's BLA for elotuzumab (Empliciti) in combination with lenalidomide and dexamethasone for multiple myeloma is summarized. The Phase 3 CA204004 trial demonstrated significant improvements in progression-free survival and overall response rate for the elotuzumab combination. However, the review also highlights safety concerns, including serious adverse events and secondary primary malignancies associated with the treatment.
Key findings — cited to the page
| PFS Hazard Ratio | 0.70 | · p.5 |
| PFS 95% CI | 0.57, 0.85 | · p.5 |
| PFS p-value | 0.0004 | · p.5 |
| median PFS | 19.4 months | · p.5 |
| median PFS (E-Ld arm) 95% CI | 16.6, 22.2 | · p.5 |
| BLA submission date | June 29, 2015 | elotuzumab · p.9 |
| BLA Number | 761035 | elotuzumab (Empliciti) · p.9 |
| median PFS (Ld arm) | 14.9 months | · p.5 |
| median PFS (Ld arm) 95% CI | 12.1, 17.2 | · p.5 |
| ORR (E-Ld arm) | 78.5 % | · p.5 |
| ORR (E-Ld arm) 95% CI | 73.6, 82.9 | · p.5 |
| Application Number | 761035Orig1s000 | · p.1 |
Source: Bristol-Myers Squibb Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →