Epcoritamab
Epcoritamab (Tepkinly, AbbVie Deutschland GmbH & Co. KG) has 3 EU-approved indications in 2 tumour types.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Large B-cell lymphoma1 | |||
None | Monotherapy | 3L+ | DLBCL only; After two or more lines of systemic therapy |
| Follicular lymphoma2 | |||
None | + lenalidomide and rituximab | 2L | None |
None | Monotherapy | 3L+ | After two or more lines of systemic therapy |
Full text of section 4.1 (therapeutic indications)
Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Label history
11 changes to the Tepkinly label since 2024, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes