Monoclonal antibody | |
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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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Pregnancy category |
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Routes of administration | Intravenous |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
DrugBank | |
UNII | |
KEGG | |
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).[4]
Tafasitamab may cause serious side effects including infusion related reactions, bone marrow suppression, infections, and harm to an unborn baby.[6] The most common side effects of tafasitamab are low blood cell counts, fatigue, diarrhea, cough, fever, limb swelling, upper respiratory infection, and decreased appetite.[6]
Tafasitamab is a humanized Fc-modified cytolytic CD19 antibody.[4][7]
Tafasitamab was approved for medical use in the United States in July 2020,[6][7][8] and in the European Union in August 2021.[5][9] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[10]
Tafasitamab, in combination with lenalidomide, is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).[4]
In the EU, minjuvi is indicated in combination with lenalidomide followed by tafasitamab monotherapy for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplant.[5]
The FDA approved tafasitamab based primarily on evidence from one clinical trial (NCT02399085) of 81 participants 42 to 86 years old.[6] Participants in the trial had lymphoma that relapsed or did not improve after prior treatments.[6] The trial was conducted at 35 sites in the United States and Europe.[6] At first, participants received tafasitamab in combination with lenalidomide and later tafasitamab alone following a specific schedule during each 28-day treatment cycle.[6] Treatment continued until disease progression or unacceptable side effects.[6] Both participants and health care providers knew which treatment had been given.[6] The benefit of tafasitamab was evaluated by measuring how many participants had a complete or partial tumor shrinkage and how long that response lasted (called best overall response rate).[6]
Tafasitamab is the international nonproprietary name (INN).[11]