Loncastuximab tesirin (1) – Zynlonta®
Diffuse large B-cell lymphoma (DLBCL) and highly malignant B-cell lymphoma (HGBL), ≥ 2 prior therapies)
Characteristics
| Start date | 15.05.2023 – Marketing authorisation: 20.12.2022 |
|---|---|
| Resolution | 02.11.2023 |
| INN | Loncastuximab tesirin |
| Brand name | Zynlonta® |
| Pharm. company | Swedish Orphan Biovitrum GmbH |
| G-BA Procedure ID | D-936 |
| ATC code | L01FX22 Other monoclonal antibodies and antibody drug conjugates (L01FX) |
| Therapeutic area | Oncological diseases |
| Reason for procedure | Initial assessment |
| Regulatory status | Conditional Approval |
| Specialty | ACT change |
Studies and Results
- Clinical trials
- The single-arm Phase II LOTIS-2 trial investigated the efficacy and safety of loncastuximab tesirin in adults with relapsed or refractory non-otherwise-specified (NOS) DLBCL, DLBCL with MYC and BCL2 and/or BCL6 rearrangements, and primary mediastinal large B-cell lymphoma (PMBCL).
a) Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) following two or more lines of systemic therapy, who are eligible for CAR-T cell therapy or stem cell transplantation
- An additional benefit is not proven.
- Overall assessment
- The results of the submitted single-arm LOTIS-2 study are not suitable for assessing additional benefit, as they do not allow for a comparison with the appropriate comparator therapy.
- Consequently, additional benefit from loncastuximab tesirin as monotherapy in adults with relapsed or refractory DLBCL and HGBL is not proven following two or more lines of systemic treatment.
b) Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) following two or more lines of systemic therapy, who are not eligible for CAR-T cell therapy or stem cell transplantation
- The additional benefit is not proven.
- Overall assessment
- The results of the single-arm LOTIS-2 study submitted are not suitable for assessing additional benefit, as they do not allow for a comparison with the appropriate comparator therapy.
- Consequently, additional benefit from loncastuximab tesirin as monotherapy in adults with relapsed or refractory DLBCL and HGBL is not proven following two or more lines of systemic treatment.
Courtesy translation only, please refer to the German original.
Associated procedures
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