Glofitamab (2) – Columvi®
Diffuse large B-cell lymphoma, relapsed or refractory, in combination with gemcitabine and oxaliplatin; autologous stem cell transplantation is not suitable
Characteristics
| Start date | 15.05.2025 – Marketing authorisation: 10.04.2025 |
|---|---|
| Resolution | 06.11.2025 |
| INN | Glofitamab |
| Brand name | Columvi® |
| Pharm. company | Roche Pharma AG |
| G-BA Procedure ID | D-1206 |
| ATC code | L01FX28 Other monoclonal antibodies and antibody drug conjugates (L01FX) |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
Studies and Results
- Clinical trials
- The STARGLO trial is an ongoing, multicentre, open-label, randomised controlled Phase III trial comparing glofitamab in combination with gemcitabine and oxaliplatin with rituximab in combination with gemcitabine and oxaliplatin.
a) Adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS), who are not suitable for autologous stem cell transplantation (ASCT), following failure of one line of systemic therapy
- The additional benefit is not proven.
- Overall, there are therefore no suitable data available to assess the additional benefit of glofitamab in combination with gemcitabine and oxaliplatin.
b1) Adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are not suitable for autologous stem cell transplantation (ASCT) and who are eligible for CAR-T cell therapy or allogeneic haematopoietic stem cell transplantation, following failure of two or more lines of systemic therapy
- The additional benefit is not proven.
- Overall, there are therefore no suitable data available to assess the additional benefit of glofitamab in combination with gemcitabine and oxaliplatin.
b2) Adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS, not otherwise specified), who are not suitable for CAR-T-cell therapy and haematopoietic stem cell transplantation, following failure of two or more lines of systemic therapy
- An additional benefit is not proven.
- Overall, there are therefore no suitable data available to assess the additional benefit of glofitamab in combination with gemcitabine and oxaliplatin.
Courtesy translation only, please refer to the German original.
Associated procedures
| Glofitamab (3) | Columvi® | Roche Pharma AG | Diffuse large B-cell lymphoma (DLBCL), following ≥ 2 prior treatments | 960–2,130 | 100% additional benefit not proven | |
| Glofitamab (2) | Columvi® | Roche Pharma AG | Diffuse large B-cell lymphoma, relapsed or refractory, in combination with gemcitabine and oxaliplatin; autologous stem cell transplantation is not suitable | 2,230–3,550 | 100% additional benefit not proven | |
| Glofitamab (1) | Columvi® | Roche Pharma AG | B-cell lymphoma, diffuse large cell (DLBCL) |
0
1,360–1,900 |
100% Hint for non-quantifiable additional benefit Orphan repealed |
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