Tafasitamab

Tafasitamab

Monoclonal antibody
Type	Whole antibody
Source	Humanized (from mouse)
Target	CD19
Clinical data
Trade names	Monjuvi, Minjuvi
Other names	tafasitamab-cxix, MOR208, Xmab5574
AHFS/Drugs.com	Monograph
License data	US DailyMed: Tafasitamab
Pregnancy category	AU: C[1]
Routes of administration	Intravenous
ATC code	L01FX12 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)[2][3] CA: ℞-only / Schedule D[4] US: ℞-only[5] EU: Rx-only[6]
Identifiers
CAS Number	1422527-84-1
DrugBank	DB15044
UNII	QQA9MLH692
KEGG	D11601
Chemical and physical data
Formula	C6550H10092N1724O2048S52
Molar mass	147425.93 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).[5]

Tafasitamab may cause serious side effects including infusion related reactions, bone marrow suppression, infections, and harm to an unborn baby.[7] The most common side effects of tafasitamab are low blood cell counts, fatigue, diarrhea, cough, fever, limb swelling, upper respiratory infection, and decreased appetite.[7]

Tafasitamab is a humanized Fc-modified cytolytic CD19 antibody.[5][8]

Tafasitamab was approved for medical use in the United States in July 2020,[7][8][9] and in the European Union in August 2021.[6][10] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[11]

Medical uses

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

In the EU, 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]

History

The FDA approved tafasitamab based primarily on evidence from one clinical trial (NCT02399085) of 81 participants 42 to 86 years old.[7] Participants in the trial had lymphoma that relapsed or did not improve after prior treatments.[7] The trial was conducted at 35 sites in the United States and Europe.[7] At first, participants received tafasitamab in combination with lenalidomide and later tafasitamab alone following a specific schedule during each 28-day treatment cycle.[7] Treatment continued until disease progression or unacceptable side effects.[7] Both participants and health care providers knew which treatment had been given.[7] 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).[7]

Society and culture

Names

Tafasitamab is the international nonproprietary name (INN).[12]

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. "Monjuvi- tafasitamab-cxix injection, powder, lyophilized, for solution". DailyMed. Archived from the original on 12 January 2021. Retrieved 17 January 2021.
6. "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. "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.
8. "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. "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.
10. "Minjuvi Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
11. "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.
12. 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

• 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