Bristol-Myers Squibb Company — Breyanzi EMA EPAR public assessment report (EMEA/H/C/004731, 2022)
Bristol-Myers Squibb Company · 2022 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted marketing authorization for Breyanzi (lisocabtagene maraleucel) for relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) and related lymphomas, following a positive CHMP opinion on January 27, 2022. The report details the manufacturing process, quality control, and non-clinical/clinical pharmacokinetics of this CD19-directed CAR T-cell therapy. Clinical studies (017001 and BCM-001) demonstrated significant efficacy (ORR, CR, PFS, OS) and an acceptable safety profile, including manageable cytokine release syndrome and neurologic toxicities. Indirect comparisons suggest Breyanzi has a favorable safety profile compared to other CAR T-cell therapies. Post-marketing commitments include long-term safety and efficacy studies.
Key findings — cited to the page
| TLS Any grade TEAEs | 0.6 % | JCAR017 · p.247 |
| Deaths due to AEs (Grade 5 AEs) | 4.6 (16/349) % (n) | JCAR017 · p.247 |
| prevalence of Grade 3 or 4 thrombocytopenia at Day 270 | 16.7 % | Study 017001 · p.227 |
| MAS Grade 5 TEAEs | 0 % | JCAR017 · p.247 |
| TLS Grade ≥ 3 TEAEs | 0.6 % | JCAR017 · p.247 |
| TLS Grade 5 TEAEs | 0 % | JCAR017 · p.247 |
| incidence of Grade ≥ 3 CRS | 2.2 % | · p.226 |
| prevalence of Grade 3 or 4 thrombocytopenia at Day 365 | 25.0 % | Study BCM-001 · p.227 |
| Grade 5 infections | 8 subjects | · p.227 |
| MAS Grade ≥ 3 TEAEs | 0.6 % | JCAR017 · p.247 |
| incidence of CRS of any grade | 41.2 % | · p.226 |
| Deaths due to AEs (Grade 5 AEs) | 4.5 (16/359) % (n) | JCAR017 · p.247 |
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 →