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 details a Type II variation application for Breyanzi (lisocabtagene maraleucel) to extend its indication to adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. The application is based on the pivotal TRANSCEND-NHL-001 study (Study 017001 MCL Cohort). The study demonstrated significant efficacy, with an overall response rate of 82.7% and a complete response rate of 71.6%, and a median duration of response of 13.3 months. Pharmacokinetic and pharmacodynamic profiles were comparable to other lymphoma cohorts. The safety profile was consistent with previous reports for liso-cel, with common adverse events including cytokine release syndrome and neurological toxicities. The report also addresses a proposed modification to a specification limit for the CD8+ drug product component and outlines ongoing pharmacovigilance and risk management plans.
Key findings — cited to the page
| p-value for Cmax (Transgene) and iiNT Grade ≥ 3 | 0.0224 | Study 017001 - MCL Cohort · p.25 |
| AUC(0-28) (Transgene) for iiNT Grade ≥ 3 | 1439165.1 | Study 017001 - MCL Cohort · p.25 |
| Grade ≥3 CART-related encephalopathy syndrome for brexucabtagene autoleucel in R/R MCL (ZUMA-2 study) | 32% | Tecartus · p.11 |
| Cmax (Transgene) for No iiNT Grade ≥ 3 | 25639.0 | Study 017001 - MCL Cohort · p.25 |
| Cmax (CD4+ EGFRt+) for No iiNT Grade ≥ 3 | 11.0 | Study 017001 - MCL Cohort · p.25 |
| p-value for Cmax (CD4+ EGFRt+) and iiNT Grade ≥ 3 | 0.0020 | Study 017001 - MCL Cohort · p.25 |
| Grade ≥3 AEs for brexucabtagene autoleucel in R/R MCL (ZUMA-2 study) | 98.5% | Tecartus · p.11 |
| Grade ≥3 CRS for brexucabtagene autoleucel in R/R MCL (ZUMA-2 study) | 13% | Tecartus · p.11 |
| Grade ≥3 infections for brexucabtagene autoleucel in R/R MCL (ZUMA-2 study) | 30% | Tecartus · p.11 |
| Cmax (Transgene) for iiNT Grade ≥ 3 | 126760.0 | Study 017001 - MCL Cohort · p.25 |
| Cmax (CD4+ EGFRt+) for iiNT Grade ≥ 3 | 84.6 | Study 017001 - MCL Cohort · p.25 |
| AUC(0-28) (Transgene) for No iiNT Grade ≥ 3 | 269192.2 | Study 017001 - MCL Cohort · p.25 |
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 →