Glofitamab
Glofitamab (Columvi, Roche Registration GmbH ) has 2 EU-approved indications in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Large B-cell lymphoma2 | |||
None | + gemcitabine and oxaliplatin | 2L | DLBCL NOS only; Ineligible for autologous stem cell transplant (ASCT) |
None | Monotherapy | 3L+ | DLBCL only; After two or more lines of systemic therapy |
Full text of section 4.1 (therapeutic indications)
Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT). Columvi 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.
Label history
7 changes to the Columvi label since 2024, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes