Tafasitamab

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Tafasitamab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetCD19
Clinical data
Trade namesMonjuvi, Minjuvi
Other namestafasitamab-cxix, MOR208, Xmab5574
AHFS/Drugs.comMonograph
License data
Routes of
administration
Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
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).[2]

Tafasitamab may cause serious side effects including infusion related reactions, bone marrow suppression, infections, and harm to an unborn baby.[4] The most common side effects of tafasitamab are low blood cell counts, fatigue, diarrhea, cough, fever, limb swelling, upper respiratory infection, and decreased appetite.[4]

Tafasitamab is a humanized Fc-modified cytolytic CD19 antibody.[2][5]

Tafasitamab was approved for medical use in the United States in July 2020.[4][5][6] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7] Tafasitamab represents an option for patients ineligible for CAR-T cell therapy. [8]

Medical uses[edit]

Tafasitamab, in combination with lenalidomide, is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).[2]

History[edit]

The FDA approved tafasitamab based primarily on evidence from one clinical trial (NCT02399085) of 81 participants 42 to 86 years old.[4] Participants in the trial had lymphoma that relapsed or did not improve after prior treatments.[4] The trial was conducted at 35 sites in the United States and Europe.[4] At first, participants received tafasitamab in combination with lenalidomide and later tafasitamab alone following a specific schedule during each 28-day treatment cycle.[4] Treatment continued until disease progression or unacceptable side effects.[4] Both participants and health care providers knew which treatment had been given.[4] 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).[4]

Society and culture[edit]

Names[edit]

Tafasitamab is the international nonproprietary name (INN).[9]

References[edit]

  1. ^ "Summary Basis of Decision (SBD) for Minjuvi". Health Canada. 23 October 2014. Retrieved 29 May 2022.
  2. ^ a b c d "Monjuvi- tafasitamab-cxix injection, powder, lyophilized, for solution". DailyMed. Retrieved 17 January 2021.
  3. ^ "Minjuvi EPAR". European Medicines Agency. 23 June 2021. Retrieved 29 May 2022.
  4. ^ 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.
  5. ^ 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.
  6. ^ "Drug Approval Package: Monjuvi". U.S. Food and Drug Administration (FDA). 27 August 2020. Retrieved 18 January 2021.
  7. ^ "New Drug Therapy Approvals 2020". U.S. Food and Drug Administration (FDA). 31 December 2020. Retrieved 17 January 2021.
  8. ^ Perrone, Salvatore; Lopedote, Paolo; Levis, Mario; Di Rocco, Alice; Smith, Stephen Douglas (21 February 2022). "Management of relapsed or refractory large B-cell lymphoma in patients ineligible for CAR-T cell therapy". Expert Review of Hematology. 15 (3): 215–232. doi:10.1080/17474086.2022.2044778. ISSN 1747-4086. PMID 35184664. S2CID 247010986.
  9. ^ 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[edit]

  • "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