Bristol-Myers Squibb Company — Abecma EMA EPAR public assessment report (EMEA/H/C/004662, 2021)
Bristol-Myers Squibb Company · 2021 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted conditional marketing authorization for Abecma (idecabtagene vicleucel), an orphan medicinal product, for adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies. This CAR T-cell therapy, granted PRIME eligibility, addresses a significant unmet medical need. Non-clinical studies confirmed product quality and dose-dependent anti-tumor activity. Clinical trials (CRB-401, MM-001/KarMMa) demonstrated a 67.1% overall response rate, a median duration of response of 10.6 months, and a median overall survival of 19.3 months. Common adverse events included cytokine release syndrome, neurotoxicity, and cytopenias. Post-authorization studies are required to provide further long-term efficacy and safety data.
Key findings — cited to the page
| Grade 3 or 4 pneumonia | 6.0% | · p.119 |
| Grade 3 or 4 infections - viral | 7.1% | · p.119 |
| Grade 3 or 4 infections - pathogen unspecified | 17.9% | · p.119 |
| Grade 3 or 4 lymphopenia | 30.4% | · p.119 |
| Grade 3 or 4 febrile neutropenia | 14.7% | · p.119 |
| Grade 3 or 4 hypocalcaemia | 7.1% | · p.119 |
| Grade 3 or 4 anaemia | 58.2% | · p.119 |
| Grade 3 or 4 neutropenia | 88.6% | · p.119 |
| Grade 3 or 4 thrombocytopenia | 53.3% | · p.119 |
| Grade 3 or 4 leukopenia | 45.1% | · p.119 |
| Grade 3 or 4 hypophosphatemia | 17.4% | · p.119 |
| Grade 3 or 4 CRS | 5.4% | · p.119 |
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 →