Tafasitamab
Pharmaceutical drug
From Wikipedia, the free encyclopedia
Tafasitamab, sold under the brand name Monjuvi, is an anti-cancer medication used in combination with lenalidomide for the treatment of adults with diffuse large B-cell lymphoma; or, when used in combination with lenalidomide and rituximab, for the treatment of follicular lymphoma.[5][7] Tafasitamab is a humanized Fc-modified cytolytic CD19 antibody.[5][8]
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | CD19 |
| Clinical data | |
| Trade names | Monjuvi, others |
| Other names | MOR208, Xmab5574, tafasitamab-cxix |
| AHFS/Drugs.com | Monograph |
| License data |
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| Pregnancy category |
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| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
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| Identifiers | |
| CAS Number | |
| DrugBank | |
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| Chemical and physical data | |
| Formula | C6550H10092N1724O2048S52 |
| Molar mass | 147425.93 g·mol−1 |
Tafasitamab may cause serious side effects including infusion related reactions, bone marrow suppression, infections, and harm to an unborn baby.[9] The most common side effects of tafasitamab are low blood cell counts, fatigue, diarrhea, cough, fever, limb swelling, upper respiratory infection, and decreased appetite.[9]
Tafasitamab was approved for medical use in the United States in July 2020,[9][8][10] and in the European Union in August 2021.[6][11] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[12]
Medical uses
Tafasitamab, in combination with lenalidomide, is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma.[5]
In the EU, tafasitamab (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]
In June 2025, the US Food and Drug Administration (FDA) expanded the indication for tafasitamab, in combination with lenalidomide and rituximab, for adults with relapsed or refractory follicular lymphoma.[7]
History
The US Food and Drug Administration (FDA) approved tafasitamab based primarily on evidence from one clinical trial (NCT02399085) of 81 participants 42 to 86 years old.[9] Participants in the trial had lymphoma that relapsed or did not improve after prior treatments.[9] The trial was conducted at 35 sites in the United States and Europe.[9] At first, participants received tafasitamab in combination with lenalidomide and later tafasitamab alone following a specific schedule during each 28-day treatment cycle.[9] Treatment continued until disease progression or unacceptable side effects.[9] Both participants and health care providers knew which treatment had been given.[9] 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).[9]
Efficacy for the treatment of follicular lymphoma was evaluated in inMIND, a double-blind, placebo-controlled trial (NCT04680052) randomizing 548 participants with relapsed or refractory follicular lymphoma to receive tafasitamab or placebo with lenalidomide and rituximab.[7] Participants had received a median of one prior line of systemic therapy; 25% and 20% had two and three or more prior lines, respectively.[7] The FDA granted the application for tafasitamab priority review and orphan drug designations for follicular lymphoma.[7]
Society and culture
Names
Tafasitamab is the international nonproprietary name (INN).[13]
Tafasitamab is sold under the brand names Monjuvi[5] and Minjuvi.[6]
