|Source||Humanized (from mouse)|
|Trade names||Monjuvi, Minjuvi, others|
|Other names||Tafasitamab-cxix, MOR208, Xmab5574|
|Main uses||Diffuse large B-cell lymphoma (DLBCL)|
|Side effects||Low white blood cells, tiredness, diarrhea, cough, fever, limb swelling, upper respiratory infection, decreased appetite|
|Typical dose||12 mg/kg|
|Chemical and physical data|
|Molar mass||147425.93 g·mol−1|
Tafasitamab, sold under the brand name Monjuvi, is a medication used to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) when autologous stem cell transplant is not an option. It is used together with lenalidomide. It is given by gradual injection into a vein.
Common side effects include low white blood cells, tiredness, diarrhea, cough, fever, limb swelling, upper respiratory infection, and decreased appetite. Other serious side effects may include infusion related reactions, bone marrow suppression, and infections. Use during pregnancy may harm the baby. It is a monoclonal antibody which attaches to CD19 and stimulates the immune system to kill the cell that expresses this.
Tafasitamab was approved for medical use in the United States in 2020 and Europe in 2021. In the United States it costs about 6400 USD per dose for a 70 kg person as of 2021. It is made by recombinant DNA technology.
Tafasitamab, in combination with lenalidomide, is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The 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 came back or did not improved 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).
Society and culture
- "Monjuvi- tafasitamab-cxix injection, powder, lyophilized, for solution". DailyMed. Archived from the original on 12 January 2021. Retrieved 17 January 2021.
- "Tafasitamab-cxix Monograph for Professionals". Drugs.com. Archived from the original on 29 August 2021. Retrieved 7 August 2021.
- "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.
- "Minjuvi". Archived from the original on 22 September 2021. Retrieved 20 September 2021.
- "Monjuvi Prices, Coupons & Patient Assistance Programs". Drugs.com. Retrieved 20 September 2021.
- "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.
- World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information. 33 (1): 118–9. hdl:10665/330896. License: CC BY-NC-SA 3.0 IGO.