Odronextamab (2) – Ordspono®
Follicular lymphoma, 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-1231 |
| 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
- In the ongoing, single-arm ELM-2 trial, patients with various tumour types (follicular lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma, marginal zone lymphoma) and treated with different dosage regimens in cohorts.
Adults with relapsed or refractory follicular lymphoma (r/r FL) following at least two lines of systemic therapy
- The additional benefit is not proven.
- Due to its single-arm design, the ELM-2 study does not allow for a comparison with the appropriate comparator therapy and is therefore not suitable for assessing the additional benefit of odronextamab.
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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