Epcoritamab (2) – Tepkinly®
Follicular lymphoma, after ≥ 2 prior therapies
Characteristics
| Start date | 15.09.2024 – Marketing authorisation: 16.08.2024 |
|---|---|
| Resolution | 06.03.2025 |
| INN | Epcoritamab |
| Brand name | Tepkinly® |
| Pharm. company | AbbVie Deutschland GmbH & Co. KG |
| G-BA Procedure ID | D-1106 |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
| Regulatory status | Conditional Approval |
Studies and Results
Adults with relapsed or refractory follicular lymphoma (FL) following at least two lines of systemic therapy
- Additional benefit is not proven for epcoritamab as monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma (FL) following at least two lines of systemic therapy.
- The results of the single-arm study do not allow for a comparison with the appropriate comparator therapy and are not suitable for assessing additional benefit.
- Consequently, additional benefit from epcoritamab as monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma (FL) is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Epcoritamab (4) | Tepkinly® | AbbVie Deutschland GmbH | Follicular lymphoma, relapsed or refractory, in combination with lenalidomide and rituximab | n.d. | active procedure | |
| Epcoritamab (3) | Tepkinly® | AbbVie Deutschland GmbH & Co. KG | Diffuse large B-cell lymphoma (DLBCL), after ≥ 2 prior therapies | 920–1,940 | 100% additional benefit not proven | |
| Epcoritamab (2) | Tepkinly® | AbbVie Deutschland GmbH & Co. KG | Follicular lymphoma, after ≥ 2 prior therapies | 370–840 | 100% additional benefit not proven | |
| Epcoritamab (1) | Tepkinly® | Abbvie Deutschland GmbH & Co. KG | Diffuse large B-cell lymphoma (DLBCL), after ≥ 2 prior therapies) |
0
1,050–1,900 |
100% Hint for non-quantifiable additional benefit Orphan repealed |
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