Tafasitamab

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Tafasitamab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetCD19
Clinical data
Trade namesMonjuvi
Other namestafasitamab-cxix, MOR208, Xmab5574
AHFS/Drugs.comMonograph
License data
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
  • 1422527-84-1
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6550H10092N1724O2048S52
Molar mass147425.93 g·mol−1

Tafasitamab, sold under the brand name Monjuvi, is a medication used in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).[1]

Tafasitamab may cause serious side effects including infusion related reactions, bone marrow suppression, infections, and harm to an unborn baby.[2] The most common side effects of tafasitamab are low blood cell counts, fatigue, diarrhea, cough, fever, limb swelling, upper respiratory infection, and decreased appetite.[2]

Tafasitamab is a humanized Fc-modified cytolytic CD19 antibody.[1][3]

Tafasitamab was approved for medical use in the United States in July 2020.[2][3][4] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[5]

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]

History[]

The FDA approved tafasitamab based primarily on evidence from one clinical trial (NCT02399085) of 81 participants 42 to 86 years old.[2] Participants in the trial had lymphoma that came back or did not improved after prior treatments.[2] The trial was conducted at 35 sites in the United States and Europe.[2] At first, participants received tafasitamab in combination with lenalidomide and later tafasitamab alone following a specific schedule during each 28-day treatment cycle.[2] Treatment continued until disease progression or unacceptable side effects.[2] Both participants and health care providers knew which treatment had been given.[2] 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).[2]

Society and culture[]

Names[]

Tafasitamab is the international nonproprietary name (INN).[6]

References[]

  1. ^ a b c d "Monjuvi- tafasitamab-cxix injection, powder, lyophilized, for solution". DailyMed. Retrieved 17 January 2021.
  2. ^ a b c d e f g h i j "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.
  3. ^ a b "FDA Approves Monjuvi (tafasitamab-cxix) in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)" (Press release). MorphoSys AG. 31 July 2020. Retrieved 31 July 2020 – via Business Wire.
  4. ^ "Drug Approval Package: Monjuvi". U.S. Food and Drug Administration (FDA). 27 August 2020. Retrieved 18 January 2021.
  5. ^ "New Drug Therapy Approvals 2020". U.S. Food and Drug Administration (FDA). 31 December 2020. Retrieved 17 January 2021.
  6. ^ 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[]

  • "Tafasitamab". Drug Information Portal. U.S. National Library of Medicine.
  • 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
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