| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (frommouse) |
| Target | CD19 |
| Clinical data | |
| Trade names | Monjuvi, Minjuvi |
| Other names | tafasitamab-cxix, MOR208, Xmab5574 |
| AHFS/Drugs.com | Monograph |
| License data | |
| Pregnancy category | |
| 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 nameMonjuvi, is a medication used in combination withlenalidomide for the treatment of adults with relapsed or refractorydiffuse 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 ahumanized 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 afirst-in-class medication.[11]
Tafasitamab, in combination with lenalidomide, isindicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).[5]
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.[6]
The FDA approved tafasitamab based primarily on evidence from one clinical trial (NCT02399085) of 81 participants 42 to 86 years old.[7] Participants in the trial had lymphoma that relapsed or did not improve after prior treatments.[7] The trial was conducted at 35 sites in the United States and Europe.[7] At first, participants received tafasitamab in combination with lenalidomide and later tafasitamab alone following a specific schedule during each 28-day treatment cycle.[7] Treatment continued until disease progression or unacceptable side effects.[7] Both participants and health care providers knew which treatment had been given.[7] 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).[7]
Tafasitamab is theinternational nonproprietary name (INN).[12]
This article incorporates text from this source, which is in thepublic domain.
