Chemistry: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 |
|
| Pregnancy category |
|
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| 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).[4]
Tafasitamab may cause serious side effects including infusion related reactions, bone marrow suppression, infections, and harm to an unborn baby.[6] The most common side effects of tafasitamab are low blood cell counts, fatigue, diarrhea, cough, fever, limb swelling, upper respiratory infection, and decreased appetite.[6]
Tafasitamab is a humanized Fc-modified cytolytic CD19 antibody.[4][7]
Tafasitamab was approved for medical use in the United States in July 2020,[6][7][8] and in the European Union in August 2021.[5][9] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[10]
Medical uses
Tafasitamab, in combination with lenalidomide, is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).[4]
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.[5]
History
The FDA approved tafasitamab based primarily on evidence from one clinical trial (NCT02399085) of 81 participants 42 to 86 years old.[6] Participants in the trial had lymphoma that relapsed or did not improve after prior treatments.[6] The trial was conducted at 35 sites in the United States and Europe.[6] At first, participants received tafasitamab in combination with lenalidomide and later tafasitamab alone following a specific schedule during each 28-day treatment cycle.[6] Treatment continued until disease progression or unacceptable side effects.[6] Both participants and health care providers knew which treatment had been given.[6] 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).[6]
Society and culture
Names
Tafasitamab is the international nonproprietary name (INN).[11]
References
- ↑ "Minjuvi". 3 July 2023. https://www.tga.gov.au/resources/auspmd/minjuvi.
- ↑ "Minjuvi (Specialised Therapeutics Alim Pty Ltd)". 28 July 2023. https://www.tga.gov.au/resources/prescription-medicines-registrations/minjuvi-specialised-therapeutics-alim-pty-ltd.
- ↑ "Summary Basis of Decision (SBD) for Minjuvi". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00560&lang=en.
- ↑ 4.0 4.1 4.2 4.3 "Monjuvi- tafasitamab-cxix injection, powder, lyophilized, for solution". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec13ac6b-bfde-4e84-907a-83bd69584d95.
- ↑ 5.0 5.1 5.2 "Minjuvi EPAR". 23 June 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/minjuvi. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ 6.00 6.01 6.02 6.03 6.04 6.05 6.06 6.07 6.08 6.09 "Drug Trial Snapshots: Monjuvi". 31 July 2020. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshots-monjuvi.
This article incorporates text from this source, which is in the public domain.
- ↑ 7.0 7.1 "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.
- ↑ "Drug Approval Package: Monjuvi". 27 August 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761163Orig1s000TOC.cfm.
- ↑ "Minjuvi Product information". https://ec.europa.eu/health/documents/community-register/html/h1570.htm.
- ↑ "New Drug Therapy Approvals 2020". 31 December 2020. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2020.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information 33 (1): 118–9. 2019. License: CC BY-NC-SA 3.0 IGO.
External links
- "Tafasitamab". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/tafasitamab.
- 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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