Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation assessment report (EMEA/H/C/004731, 2022)
Bristol-Myers Squibb Company · 2022 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes Bristol-Myers Squibb's Type II variation application for Breyanzi (lisocabtagene maraleucel) to extend its indication to second-line transplant-intended large B-cell lymphoma (LBCL) in adults. Based on the pivotal Phase III TRANSFORM study (BCM-003), Breyanzi demonstrated statistically significant improvements in event-free survival, complete response rate, and progression-free survival compared to standard of care. While overall survival showed a positive trend, it was not statistically significant in primary analyses. The manufacturing process, quality control, and pharmacokinetic/pharmacodynamic profiles were assessed. The safety profile was consistent with other CAR T-cell products, with common adverse events including neutropenia, anemia, and thrombocytopenia, and a low incidence of severe cytokine release syndrome. Risk management plans are in place for ongoing pharmacovigilance.
Key findings — cited to the page
| Grade ≥ 3 decreased platelets (thrombocytopenia) in liso-cel arm | 37.0 % | BCM-003 · p.147 |
| Grade ≥ 3 decreased platelets (thrombocytopenia) in SOC arm | 0 | BCM-003 · p.147 |
| Grade ≥ 3 decreased neutrophils (neutropenia) in liso-cel arm | 37.0 % | BCM-003 · p.147 |
| Grade ≥ 3 decreased neutrophils (neutropenia) in SOC arm | 2.2 % | BCM-003 · p.147 |
| Grade ≥ 3 laboratory-based prolonged cytopenia in liso-cel arm | 43.5 % | BCM-003 · p.147 |
| Grade ≥ 3 CRS in liso-cel arm | 1 subject | BCM-003 · p.142 |
| Grade 3-4 TEAEs in liso-cel arm | 92.4 % | BCM-003 · p.134 |
| Grade ≥ 3 laboratory-based prolonged cytopenia in SOC arm | 3.3 % | BCM-003 · p.147 |
| High-grade B cell lymphoma | 21 subjects | SOC arm · p.62 |
| High-grade B cell lymphoma | 22 subjects | Breyanzi arm · p.62 |
| Grade 3-4 TEAEs in SOC arm | 86.8 % | BCM-003 · p.134 |
| Grade ≥ 3 decreased hemoglobin (anemia) in liso-cel arm | 12.0 % | BCM-003 · p.147 |
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 →