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) |
| ICD-10 codes (AIS) | C82.0Follicular lymphoma grade I, C82.1Follicular lymphoma grade II, C82.2Follicular lymphoma grade III, unspecified, C82.3Follicular lymphoma grade IIIa, C82.4Follicular lymphoma grade IIIb, C82.7, C82.9Follicular lymphoma, unspecified |
| Alpha-ID codes (AIS) | I116042Follicular lymphoma grade 1, I116043Follicular lymphoma grade 2, I116044Follicular lymphoma grade 3, I116045Follicular lymphoma grade 3a, I116046Follicular lymphoma grade 3b, I116049Other types of follicular lymphoma, I17968Follicular lymphoma |
| Therapeutic area | Oncological diseases |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
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Ordspono is used as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) following two or more lines of systemic therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Erwachsene mit einem rezidivierenden oder refraktären follikulären Lymphom (r/r FL) nach mindestens zwei Linien einer systemischen Therapie |
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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