Tafasitamab

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Tafasitamab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetCD19
Names
Trade namesMonjuvi, Minjuvi, others
Other namesTafasitamab-cxix, MOR208, Xmab5574
Clinical data
Main usesDiffuse large B-cell lymphoma (DLBCL)[1]
Side effectsLow white blood cells, tiredness, diarrhea, cough, fever, limb swelling, upper respiratory infection, decreased appetite[2][3]
Routes of
use
Intravenous
Typical dose12 mg/kg[1]
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status
Chemical and physical data
FormulaC6550H10092N1724O2048S52
Molar mass147425.93 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.[1] It is used together with lenalidomide.[1] It is given by gradual injection into a vein.[4]

Common side effects include low white blood cells, tiredness, diarrhea, cough, fever, limb swelling, upper respiratory infection, and decreased appetite.[2][3] Other serious side effects may include infusion related reactions, bone marrow suppression, and infections.[3] Use during pregnancy may harm the baby.[3] It is a monoclonal antibody which attaches to CD19 and stimulates the immune system to kill the cell that expresses this.[4]

Tafasitamab was approved for medical use in the United States in 2020 and Europe in 2021.[2][4] In the United States it costs about 6400 USD per dose for a 70 kg person as of 2021.[5] It is made by recombinant DNA technology.[2]

Medical uses

Tafasitamab, in combination with lenalidomide, is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).[1]

Dosage

It is used at a dose of 12 mg/kg.[1] It is give on 5 days in the first 4 weeks, than on 4 days in the two subsequent 4 weeks periods, and finally twice every 4 weeks.[1]

History

The FDA approved tafasitamab based primarily on evidence from one clinical trial (NCT02399085) of 81 participants 42 to 86 years old.[3] Participants in the trial had lymphoma that came back or did not improved after prior treatments.[3] The trial was conducted at 35 sites in the United States and Europe.[3] At first, participants received tafasitamab in combination with lenalidomide and later tafasitamab alone following a specific schedule during each 28-day treatment cycle.[3] Treatment continued until disease progression or unacceptable side effects.[3] Both participants and health care providers knew which treatment had been given.[3] 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).[3]

The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[6]

Society and culture

Names

Tafasitamab is the international nonproprietary name (INN).[7]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 "Monjuvi- tafasitamab-cxix injection, powder, lyophilized, for solution". DailyMed. Retrieved 17 January 2021.
  2. 2.0 2.1 2.2 2.3 "Tafasitamab-cxix Monograph for Professionals". Drugs.com. Retrieved 7 August 2021.
  3. 3.00 3.01 3.02 3.03 3.04 3.05 3.06 3.07 3.08 3.09 3.10 "Drug Trial Snapshots: Monjuvi". U.S. Food and Drug Administration (FDA). 31 July 2020. Retrieved 17 January 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  4. 4.0 4.1 4.2 "Minjuvi". Retrieved 20 September 2021.
  5. "Monjuvi Prices, Coupons & Patient Assistance Programs". Drugs.com. Retrieved 20 September 2021.
  6. "New Drug Therapy Approvals 2020". U.S. Food and Drug Administration (FDA). 31 December 2020. Retrieved 17 January 2021.
  7. 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.

External links

External sites:
Identifiers:
  • Clinical trial number NCT02399085 for "A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL (L-MIND)" at ClinicalTrials.gov