Tafasitamab

Tafasitamab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetCD19
Clinical data
Trade namesMonjuvi, others
Other namesMOR208, Xmab5574, tafasitamab-cxix
AHFS/Drugs.comMonograph
License data
Pregnancy
category
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 an anti-cancer medication used in combination with lenalidomide for the treatment of adults with diffuse large B-cell lymphoma; or, when used in combination with lenalidomide and rituximab, for the treatment of follicular lymphoma.[5][7] Tafasitamab is a humanized Fc-modified cytolytic CD19 antibody.[5][8]

Tafasitamab may cause serious side effects including infusion related reactions, bone marrow suppression, infections, and harm to an unborn baby.[9] The most common side effects of tafasitamab are low blood cell counts, fatigue, diarrhea, cough, fever, limb swelling, upper respiratory infection, and decreased appetite.[9]

Tafasitamab was approved for medical use in the United States in July 2020,[9][8][10] and in the European Union in August 2021.[6][11] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[12]

Medical uses

Tafasitamab, in combination with lenalidomide, is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma.[5]

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.[6]

In June 2025, the US Food and Drug Administration (FDA) expanded the indication for tafasitamab, in combination with lenalidomide and rituximab, for adults with relapsed or refractory follicular lymphoma.[7]

History

The US Food and Drug Administration (FDA) approved tafasitamab based primarily on evidence from one clinical trial (NCT02399085) of 81 participants 42 to 86 years old.[9] Participants in the trial had lymphoma that relapsed or did not improve after prior treatments.[9] The trial was conducted at 35 sites in the United States and Europe.[9] At first, participants received tafasitamab in combination with lenalidomide and later tafasitamab alone following a specific schedule during each 28-day treatment cycle.[9] Treatment continued until disease progression or unacceptable side effects.[9] Both participants and health care providers knew which treatment had been given.[9] 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).[9]

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.[7] Participants had received a median of one prior line of systemic therapy; 25% and 20% had two and three or more prior lines, respectively.[7] The FDA granted the application for tafasitamab priority review and orphan drug designations for follicular lymphoma.[7]

Society and culture

Names

Tafasitamab is the international nonproprietary name (INN).[13]

Tafasitamab is sold under the brand names Monjuvi[5] and Minjuvi.[6]

References

  1. ^ "Minjuvi". Therapeutic Goods Administration (TGA). 3 July 2023. Archived from the original on 8 November 2023. Retrieved 10 September 2023.
  2. ^ "Minjuvi (Specialised Therapeutics Alim Pty Ltd)". Therapeutic Goods Administration (TGA). 28 July 2023. Archived from the original on 11 September 2023. Retrieved 10 September 2023.
  3. ^ "AusPAR: Minjuvi - Australian Public Assessment Report". www.tga.gov.au.
  4. ^ "Summary Basis of Decision (SBD) for Minjuvi". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  5. ^ a b c d e "Monjuvi- tafasitamab-cxix injection, powder, lyophilized, for solution". DailyMed. Archived from the original on 12 January 2021. Retrieved 17 January 2021.
  6. ^ a b c d "Minjuvi EPAR". European Medicines Agency. 23 June 2021. Archived from the original on 22 September 2021. Retrieved 29 May 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. ^ a b c d e "FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma". U.S. Food and Drug Administration (FDA). 18 June 2025. Retrieved 20 June 2025. This article incorporates text from this source, which is in the public domain.
  8. ^ 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. Archived from the original on 2 August 2020. Retrieved 31 July 2020 – via Business Wire.
  9. ^ a b c d e f g h i j "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.
  10. ^ "Drug Approval Package: Monjuvi". U.S. Food and Drug Administration (FDA). 27 August 2020. Archived from the original on 5 March 2021. Retrieved 18 January 2021.
  11. ^ "Minjuvi Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
  12. ^ "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.
  13. ^ 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.
  • 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
  • Clinical trial number NCT04680052 for "A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. (InMIND)" at ClinicalTrials.gov
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