Tafasitamab
Tafasitamab (Minjuvi, Incyte Biosciences Distribution B.V.) has 2 EU-approved indications in 2 tumour types.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Large B-cell lymphoma1 | |||
None | + lenalidomide followed by monotherapy | 2L | DLBCL only; Not eligible for autologous stem cell transplant (ASCT) |
| Follicular lymphoma1 | |||
None | + lenalidomide and rituximab | 2L | After at least one line of systemic therapy; Grade 1-3a |
Full text of section 4.1 (therapeutic indications)
MINJUVI is indicated in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). MINJUVI is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.
Label history
11 changes to the Minjuvi label since 2022, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes