Global InformationTafasitamab information
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | CD19 |
| Clinical data | |
| Trade names | Monjuvi, Minjuvi |
| Other names | tafasitamab-cxix, MOR208, Xmab5574 |
| AHFS/Drugs.com | Monograph |
| License data |
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| Routes of administration | Intravenous |
| ATC code |
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| Legal status | |
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| Identifiers | |
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| Chemical and physical data | |
| Formula | C6550H10092N1724O2048S52 |
| Molar mass | 147425.93 g·mol−1 |
Tafasitamab, sold under the brand name Monjuvi, is a medication used in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).[5]
Tafasitamab may cause serious side effects including infusion related reactions, bone marrow suppression, infections, and harm to an unborn baby.[7] The most common side effects of tafasitamab are low blood cell counts, fatigue, diarrhea, cough, fever, limb swelling, upper respiratory infection, and decreased appetite.[7]
Tafasitamab is a humanized Fc-modified cytolytic CD19 antibody.[5][8]
Tafasitamab was approved for medical use in the United States in July 2020,[7][8][9] and in the European Union in August 2021.[6][10] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[11]
- ^ "Minjuvi". Therapeutic Goods Administration (TGA). 3 July 2023. Archived from the original on 8 November 2023. Retrieved 10 September 2023.
- ^ "Minjuvi (Specialised Therapeutics Alim Pty Ltd)". Therapeutic Goods Administration (TGA). 28 July 2023. Archived from the original on 11 September 2023. Retrieved 10 September 2023.
- ^ https://www.tga.gov.au/resources/auspar/auspar-minjuvi
- ^ "Summary Basis of Decision (SBD) for Minjuvi". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
- ^ a b c "Monjuvi- tafasitamab-cxix injection, powder, lyophilized, for solution". DailyMed. Archived from the original on 12 January 2021. Retrieved 17 January 2021.
- ^ a b "Minjuvi EPAR". European Medicines Agency. 23 June 2021. Archived from the original on 22 September 2021. Retrieved 29 May 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b c "Drug Trial Snapshots: Monjuvi". U.S. Food and Drug Administration (FDA). 31 July 2020. Archived from the original on 22 December 2020. Retrieved 17 January 2021.
This article incorporates text from this source, which is in the public domain.
- ^ a b "FDA Approves Monjuvi (tafasitamab-cxix) in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)" (Press release). MorphoSys AG. 31 July 2020. Archived from the original on 2 August 2020. Retrieved 31 July 2020 – via Business Wire.
- ^ "Drug Approval Package: Monjuvi". U.S. Food and Drug Administration (FDA). 27 August 2020. Archived from the original on 5 March 2021. Retrieved 18 January 2021.
- ^ "Minjuvi Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
- ^ "New Drug Therapy Approvals 2020". U.S. Food and Drug Administration (FDA). 31 December 2020. Archived from the original on 18 January 2021. Retrieved 17 January 2021.
