Monjuvi FDA Approval History
Last updated by Judith Stewart, BPharm on June 22, 2025.
FDA Approved: Yes (First approved July 31, 2020)
Brand name: Monjuvi
Generic name: tafasitamab-cxix
Dosage form: for Injection
Company: Incyte Corporation
Treatment for: Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
Monjuvi (tafasitamab-cxix) is a CD19-directed cytolytic antibody used in the treatment of diffuse large B-cell lymphoma and follicular lymphoma.
- Monjuvi is indicated:
- 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, and who are not eligible for autologous stem cell transplant (ASCT).
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.
Development timeline for Monjuvi
Further information
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