Breyanzi(liso-cel)
Oncology· 2364 cited findings· 5 source documents
Company: Bristol-Myers Squibb Company →
What the regulatory reviews say
Breyanzi (liso-cel) is under regulatory review for a proposed new therapeutic indication for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. The pivotal study for this MCL indication is Study 017001 MCL Cohort (TRANSCEND-NHL-001), with a data cutoff for the Final Analysis on 16-May-2024 and a follow-up duration of 24 months. For brexucabtagene autoleucel in R/R MCL (ZUMA-2 study), the Overall Response Rate (ORR) was 91% and the Complete Response Rate (CRR) was 68%, with a median Duration of Response (DOR) of 28.2 months. In comparison, ibrutinib in R/R MCL showed an ORR of 72% and a median PFS of 14.6 months, while temsirolimus in R/R MCL had an ORR of 40% and a median PFS of 6.2 months. Pirtobrutinib in R/R MCL (BRUIN study) demonstrated an ORR of 56.7%.
Safety findings for brexucabtagene autoleucel in R/R MCL (ZUMA-2 study) included Grade ≥3 AEs in 98.5% of patients, Grade ≥3 Cytokine Release Syndrome (CRS) in 13%, Grade ≥3 CART-related encephalopathy syndrome in 32%, and Grade ≥3 infections in 30%. Deaths due to progressive disease (PD) were observed in 7 out of 139 (5%) subjects. The regulatory submission for this Type II variation was made on 07 April 2025, with a CHMP opinion date of 16 October 2025. A 1-year market protection extension has been requested.
Key figures — cited to the source page
| ORR for brexucabtagene autoleucel in R/R MCL (ZUMA-2 study) | 91% | Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation a, p.11 |
| CRR for brexucabtagene autoleucel in R/R MCL (ZUMA-2 study) | 68% | Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation a, p.11 |
| Median DOR for brexucabtagene autoleucel in R/R MCL (ZUMA-2 study) | 28.2 months | Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation a, p.11 |
| ORR for ibrutinib in R/R MCL | 72% | Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation a, p.10 |
| Median PFS for ibrutinib in R/R MCL | 14.6 months | Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation a, p.10 |
| Grade ≥3 AEs for brexucabtagene autoleucel in R/R MCL (ZUMA-2 study) | 98.5% | Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation a, p.11 |
| Deaths due to PD | 7/139 (5%) | Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation a, p.140 |
| Proposed new therapeutic indication | treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor | Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation a, p.8 |
Source documents
- Bristol-Myers Squibb Company — Breyanzi EMA EPAR public assessment report (EMEA/H/C/004731, 2022) (2022)
- Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation assessment report (EMEA/H/C/004731, 2022) (2022)
- Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation assessment report (EMEA/H/C/004731, 2022) (2022)
- Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation assessment report (EMEA/H/C/004731, 2022) (2022)
- Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation assessment report (EMEA/H/C/004731, 2022) (2022)
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.