Tafasitamab (Monjuvi)
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Mechanism of action
Anti-CD19 antibody with an engineered Fc region to enhance Fcγ receptor binding affinity
Diseases for which it is used
History of changes in FDA indication
- 2020-07-31: Granted accelerated approval in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant. (Based on L-MIND)
History of changes in EMA indication
- 2021-08-26: Initial conditional approval as Minjuvi
History of changes in Health Canada indication
- 2021-08-19: Initial notice of compliance with conditions in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant (ASCT)
Also known as
- Code names: MOR-208, MOR-00208, XmAb-5574
- Generic name: tafasitamab-cxix
- Brand name: Minjuvi, Monjuvi