Difference between revisions of "Tafasitamab (Monjuvi)"
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==History of changes in FDA indication== | ==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|diffuse large B-cell lymphoma (DLBCL) not otherwise specified]], including [[Transformed lymphoma|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== | ==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|diffuse large B-cell lymphoma (DLBCL) not otherwise specified]], including [[Transformed lymphoma|DLBCL arising from low grade lymphoma]], who are not eligible for autologous stem cell transplant (ASCT) | ||
==Also known as== | ==Also known as== | ||
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[[Category:EMA approved in 2021]] | [[Category:EMA approved in 2021]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
| + | [[Category:Health Canada approved in 2021]] | ||
Revision as of 01:24, 31 March 2023
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: MOR208, MOR00208, XmAb5574
- Generic name: tafasitamab-cxix
- Brand name: Minjuvi, Monjuvi