Tafasitamab, sold under the brand name Monjuvi, is an

anti-cancer medication Chemotherapy (often abbreviated chemo, sometimes CTX and CTx) is the type of cancer treatment that uses one or more anti-cancer drugs ( chemotherapeutic agents or alkylating agents) in a standard regimen. Chemotherapy may be given with a cu ...

used in combination with

lenalidomide Lenalidomide, sold under the brand name Revlimid among others, is a medication used to treat multiple myeloma, smoldering myeloma, and myelodysplastic syndromes (MDS). For multiple myeloma, it is a first-line treatment, and is given with dexa ...

for the treatment of adults with

diffuse large B-cell lymphoma Diffuse large B-cell lymphoma (DLBCL) is a cancer of B cells, a type of lymphocyte that is responsible for producing antibodies. It is the most common form of non-Hodgkin lymphoma among adults, with an annual incidence of 7–8 cases per 100,000 ...

; or, when used in combination with lenalidomide and

rituximab Rituximab, sold under the brand name Rituxan among others, is a monoclonal antibody medication used to treat certain autoimmune diseases and types of cancer. It is used for non-Hodgkin lymphoma, chronic lymphocytic leukemia (in children and ad ...

, for the treatment of

follicular lymphoma Follicular lymphoma (FL) is a cancer that involves certain types of white blood cells known as lymphocytes. This cancer is a form of Non-Hodgkin Lymphoma and it originates from the uncontrolled division of specific types of B-cells ( centrocytes ...

. Tafasitamab is a

humanized Humanized antibodies are antibodies from non-human species whose protein sequences have been modified to increase their similarity to antibody variants produced naturally in humans. The process of "humanization" is usually applied to monoclonal ant ...

Fc-modified cytolytic CD19 antibody. Tafasitamab may cause serious side effects including infusion related reactions, bone marrow suppression, infections, and harm to an unborn baby. The most common side effects of tafasitamab are low blood cell counts, fatigue, diarrhea, cough, fever, limb swelling, upper respiratory infection, and decreased appetite. Tafasitamab was approved for medical use in the United States in July 2020, and in the European Union in August 2021. The US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) considers it to be a

first-in-class medication A first-in-class medication is a prototype drug that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medic ...

Medical uses

Tafasitamab, in combination with

, is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma. 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. In June 2025, the US

(FDA) expanded the indication for tafasitamab, in combination with lenalidomide and

, for adults with relapsed or refractory follicular lymphoma.

History

The US

(FDA) approved tafasitamab based primarily on evidence from one clinical trial (NCT02399085) of 81 participants 42 to 86 years old. Participants in the trial had lymphoma that relapsed or did not improve after prior treatments. The trial was conducted at 35 sites in the United States and Europe. At first, participants received tafasitamab in combination with lenalidomide and later tafasitamab alone following a specific schedule during each 28-day treatment cycle. Treatment continued until disease progression or unacceptable side effects. Both participants and health care providers knew which treatment had been given. 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). 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. Participants had received a median of one prior line of systemic therapy; 25% and 20% had two and three or more prior lines, respectively. The FDA granted the application for tafasitamab

priority review Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program ...

and

orphan drug An orphan drug is a medication, pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by th ...

designations for follicular lymphoma.

Society and culture

Names

Tafasitamab is the international nonproprietary name (INN). Tafasitamab is sold under the brand names Monjuvi and Minjuvi.

References

External links

* * {{Authority control Monoclonal antibodies for tumors Orphan drugs