Lisocabtagen maraleucel (1) – Breyanzi®
Diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma and follicular lymphoma (PMBCL) grade 3B, after ≥ 2 prior therapies
Characteristics
| Start date | 01.09.2022 – Marketing authorisation: 04.04.2022 |
|---|---|
| Resolution | 06.04.2023 |
| Limitation date | 15.10.2023 limitation repealed |
| INN | Lisocabtagen maraleucel |
| Brand name | Breyanzi® |
| Pharm. company | Bristol-Myers Squibb GmbH |
| G-BA Procedure ID | D-867 |
| ATC code | L01XL08 OTHER ANTINEOPLASTIC AGENTS (L01X) |
| ICD-10 codes (AIS) | C82.4Follicular lymphoma grade IIIb, C83.3Diffuse large B-cell lymphoma, C85.1Unspecified B-cell lymphoma, C85.2Mediastinal (thymic) large B-cell lymphoma |
| Alpha-ID codes (AIS) | I110892Highly malignant B-cell lymphoma, I114432Diffuse large B-cell lymphoma, I116046Follicular lymphoma grade 3b, I131597Primary mediastinal large B-cell lymphoma |
| DDD | 1 P |
| Therapeutic area | Oncological diseases Follicular lymphoma (FL), Wound care / Debridement |
| Reason for procedure | Initial assessment |
| Regulatory status | ATMP (CAR-T) |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
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Breyanzi is used to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and grade 3B follicular lymphoma (FL3B) in adult patients after two or more lines of systemic therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and grade 3B follicular lymphoma (FL3B) after two or more lines of systemic therapy | Patient-specific therapy with selection of: – CEOP (cyclophosphamide, etoposide, vincristine, prednisone), – dose-adjusted EPOCH (etoposide, vincristine, doxorubicin, cyclophosphamide, prednisone), – MINE (mesna, ifosfamide, mitoxantrone, etoposide), – Polatuzumab vedotin + bendamustine + rituximab (only for individuals with DLBCL, who are not eligible for hematopoietic stem cell transplantation), polatuzumab), – Tafasitamab + lenalidomide (only for individuals with DLBCL who are ineligible for autologous Stem cell transplantation is not an option), – Monotherapy Pixantrone, – Monotherapy rituximab (only for individuals with FL3B), – Tisagenlecleucel (only for individuals with DLBCL and FL3B), – Axicabtagen-ciloleucel (only for individuals with DLBCL and PMBCL), – Radiation, – Stem cell transplantation (autologous or allogeneic), – or best-supportive-care |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (ANSCEND-NHL-001, TRANSCEND WORLD) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Single-arm + historical comparison) |
| ACT change | 06.04.2023 – BSG-Urteil zum Solitenstatus |
- Clinical trials
- The TRANSCEND-NHL-001 study is a single-arm Phase I/II cohort study investigating lisocabtagen maraleucel in patients with mantle cell lymphoma and DLBCL.
- The NDS-NHL-001 study is a retrospective study conducted by the pharmaceutical manufacturer to investigate the treatment of patients with aggressive B-cell NHL who have relapsed or are refractory to treatment following at least two prior lines of therapy.
- The ZUMA-1 study is a single-arm Phase I/II study investigating the efficacy and safety of axicabtagen-ciloleucel in patients with refractory DLBCL, PMBCL or transformed FL.
- The JULIET trial is a single-arm Phase II trial investigating tisagenlecleucel in adults with relapsed or refractory DLBCL.
Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and grade 3B follicular lymphoma (FL3B) following two or more lines of systemic therapy
- Additional benefit is not proven for lisocabtagen maraleucel in adults with relapsed or refractory diffuse DLBCL, PMBCL and FL3B following two or more lines of systemic therapy.
- Overall assessment
- The indirect comparisons presented are subject to major uncertainties. This is primarily due to the lack of comparability between the respective patient populations, as well as to relevant differences in the study designs of the trials on CAR-T cell therapies.
- Overall, the data presented are therefore not suitable for demonstrating additional benefit compared with the appropriate comparator therapy; consequently, the additional benefit of lisocabtagen maraleucel in adults with relapsed or refractory DLBCL, PMBCL and FL3B following two or more lines of systemic therapy are not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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