Monoclonal antibody | |
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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 |
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Pregnancy category |
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Routes of administration | Intravenous |
ATC code | |
Legal status | |
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Identifiers | |
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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]
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]
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]
Tafasitamab is the international nonproprietary name (INN). [12]
Diffuse large B-cell lymphoma (DLBCL) is a cancer of B cells, a type of lymphocyte that is responsible for producing antibodies. It is the most common form of non-Hodgkin lymphoma among adults, with an annual incidence of 7–8 cases per 100,000 people per year in the US and UK. This cancer occurs primarily in older individuals, with a median age of diagnosis at ~70 years, although it can occur in young adults and, in rare cases, children. DLBCL can arise in virtually any part of the body and, depending on various factors, is often a very aggressive malignancy. The first sign of this illness is typically the observation of a rapidly growing mass or tissue infiltration that is sometimes associated with systemic B symptoms, e.g. fever, weight loss, and night sweats.
Elotuzumab, sold under the brand name Empliciti, is a humanized IgG1 monoclonal antibody medication used in combination with lenalidomide and dexamethasone, for adults that have received 1 to 3 prior therapies for the treatment of multiple myeloma. It is also indicated for adult patients in combination with pomalidomide and dexamethasone, who have received 2 prior therapies including lenalidomide and a protease inhibitor. Administration of elotuzumab is done intravenously. Each intravenous injection of elotuzumab should be premedicated with dexamethasone, diphenhydramine, ranitidine and acetaminophen. It is being developed by Bristol Myers Squibb and AbbVie.
MorphoSys AG is a German biopharmaceutical company founded in 1992. The company is headquartered near Munich, Germany, and has a wholly owned subsidiary, MorphoSys US Inc., in Boston, Massachusetts, in the US. The company has various antibody, protein and peptide technologies that it uses to discover and develop both proprietary and partnered drug candidates. The company has more than 100 drugs in its wider pipeline that are being investigated for a variety of diseases. While many of these are being developed in partnership with pharma and biotech companies, MorphoSys also has a proprietary pipeline with a focus on cancer and autoimmune diseases.
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