Bristol-Myers Squibb Company — Abecma EMA EPAR variation assessment report (EMEA/H/C/004662, 2021)
Bristol-Myers Squibb Company · 2021 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes a Type II variation application for Abecma (idecabtagene vicleucel) to expand its indication for adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies. The application is supported by the Phase 3 KarMMa-3 (MM-003) study, which demonstrated statistically significant improvements in progression-free survival (PFS) and overall response rate (ORR) for ide-cel compared to standard regimens. While overall survival (OS) data were confounded by crossover, the study showed a median PFS of 13.3 months versus 4.4 months. Quality, non-clinical, and clinical pharmacology aspects, including exposure-response relationships, were assessed. Safety analysis highlighted adverse events like cytokine release syndrome and neurotoxicity, consistent with previous observations. The variation was accepted, leading to updates in product information and risk minimization measures.
Key findings — cited to the page
| percentage of Grade 3 or 4 infections (ide-cel arm) | 22.2 % | MM-003 study · p.102 |
| severity grade of CRS symptoms (Grade 3-4, MM-003) | 17.8 % | MM-003 · p.138 |
| Grade 5 CRS (ide-cel arm) | 0.9 % | MM-003 study · p.102 |
| Grade 3 or 4 infections (ide-cel arm) | 50 subjects | MM-003 study · p.102 |
| percentage of Grade 3 or 4 infections (standard regimens arm) | 18.3 % | MM-003 study · p.102 |
| subjects with at least 1 MAS AE (Grade 3/4) | 2.2 % | MM-003 · p.103 |
| Grade 3 CRS (ide-cel arm) | 2.7 % | MM-003 study · p.102 |
| Grade 4 CRS (ide-cel arm) | 1.3 % | MM-003 study · p.102 |
| Grade 3-4 iiNT (ide-cel arm) | 7 subjects | MM-003 study · p.102 |
| percentage of Grade 3-4 iiNT (ide-cel arm) | 3.1 % | MM-003 study · p.102 |
| Grade 3 or 4 infections (standard regimens arm) | 23 subjects | MM-003 study · p.102 |
| rate of >= Grade 3 CRS events (pooled studies) | 5.4 % | · p.138 |
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 →