Odronextamab (1) – Ordspono®
Diffuse large B-cell lymphoma (DLBCL), following ≥ 2 prior treatments
Characteristics
| Start date | 01.08.2025 – Marketing authorisation: 22.08.2024 |
|---|---|
| Resolution | 22.01.2026 |
| INN | Odronextamab |
| Brand name | Ordspono® |
| Pharm. company | Regeneron GmbH |
| G-BA Procedure ID | D-1230 |
| ATC code | L01FX34 Other monoclonal antibodies and antibody drug conjugates (L01FX) |
| Therapeutic area | Oncological diseases |
| Reason for procedure | Initial assessment |
Studies and Results
- Clinical trials
- The ELM-1 trial has been underway since January 2015 at 17 centres in North America, Europe and Israel.
- The ELM-2 trial has been underway since November 2019 at 92 centres in Asia, Australia, North America and Europe.
a) Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least two previous systemic therapies, who are eligible for CAR-T cell therapy or stem cell transplantation
- An additional benefit is not proven.
b) Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least two prior systemic therapies, who are not eligible for CAR-T cell therapy or stem cell transplantation
- The additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Odronextamab (2) | Ordspono® | Regeneron GmbH | Follicular lymphoma, following ≥ 2 prior treatments | 370–840 | 100% additional benefit not proven | |
| Odronextamab (1) | Ordspono® | Regeneron GmbH | Diffuse large B-cell lymphoma (DLBCL), following ≥ 2 prior treatments | 960–2,130 | 100% additional benefit not proven |
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