Tafasitamab: First Approval

Hoy, Sheridan M.

doi:10.1007/s40265-020-01405-w

Cited by 24 publications

(17 citation statements)

References 13 publications

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“…The drug induces B-cell lysis via apoptosis and immune effector mechanisms, i.e., antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). In the structure of the Fc region of tafasitamab-cxix , two amino acids were substituted, resulting in increased Fcγ receptor affinity compared with a non-engineered anti-CD19 mAbs [ 199 ]. The drug is used in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL, who are not eligible for autologous stem cell transplant (ASCT) [ 200 ].…”

Section: Macromolecule Anticancer Drugsmentioning

confidence: 99%

FDA-Approved Drugs for Hematological Malignancies—The Last Decade Review

Sochacka-Ćwikła

Mączyński

Regiec

2021

Cancers

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Hematological malignancies, also referred to as blood cancers, are a group of diseases involving abnormal cell growth and persisting in the blood, lymph nodes, or bone marrow. The development of new targeted therapies including small molecule inhibitors, monoclonal antibodies, bispecific T cell engagers, antibody-drug conjugates, recombinant immunotoxins, and, finally, Chimeric Antigen Receptor T (CAR-T) cells has improved the clinical outcomes for blood cancers. In this review, we summarized 52 drugs that were divided into small molecule and macromolecule agents, approved by the Food and Drug Administration (FDA) in the period between 2011 and 2021 for the treatment of hematological malignancies. Forty of them have also been approved by the European Medicines Agency (EMA). We analyzed the FDA-approved drugs by investigating both their structures and mechanisms of action. It should be emphasized that the number of targeted drugs was significantly higher (46 drugs) than chemotherapy agents (6 drugs). We highlight recent advances in the design of drugs that are used to treat hematological malignancies, which make them more effective and less toxic.

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Section: Macromolecule Anticancer Drugsmentioning

confidence: 99%

FDA-Approved Drugs for Hematological Malignancies—The Last Decade Review

Sochacka-Ćwikła

Mączyński

Regiec

2021

Cancers

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“…Tafasitamab (also known as Monjuvi ® , tafasitamab-cxix, MOR208, and XmAb5574) is a humanized monoclonal antibody with great targeting ability and specificity towards CD19 developed by MorphoSys AG (26)(27)(28)(29)(30). CD19 is a surface antigen that is expressed from the early developmental stages of pro-B-cells until its downregulation at the final differentiation stage of B cells, in which they develop into antibody-secreting plasma cells (26).…”

Section: Tafasitamabmentioning

confidence: 99%

Monoclonal Antibodies (mAbs) Approved for Cancer Treatment in the 2020s

et al. 2021

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: Monoclonal antibodies are one of the most eminent types of immunotherapeutics that have taken over the biopharmaceutical market because they are approved for a wide range of cancers, either blood-based malignancies or solid tumors, and also non-cancer indications, from migraine to viral infections. Due to their wide applicability as immunotherapeutics, countless biopharmaceutical companies try to be in the competition by developing monoclonal antibodies and advancing into clinical trials with them. Since the approval of the first monoclonal antibodies, the speed of their discovery and approval for medical use have been rather incremental, so that the progress of this market has been anticipated to increase in the current decade. Herein, we take a look at some of the monoclonal antibodies, which have been approved for clinical use in the current decade, so far. Moreover, we underline the encouraging results from the clinical trials that led to the approval of these immunotherapeutics.

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“…Although the antibody is relatively well tolerated, an increased risk of infections resulting from profound B cell depletion is a major concern [ 7 ]. Although CD19 appears to be more attractive than CD20 with respect to its broader expression on immature and differentiated B cells (plasma cells), clinical development of monospecific anti-CD19 antibodies is far less advanced [ 8 ]. Possibly due to its less pronounced expression, CD19 targeting was mainly used by T cell recruiting strategies, where limited numbers of target molecules per cell are less critical.…”

Section: Introductionmentioning

confidence: 99%

IgG-Based Bispecific Anti-CD95 Antibodies for the Treatment of B Cell-Derived Malignancies and Autoimmune Diseases

Hörner

Moustafa-Oglou²,

Teppert³

et al. 2022

Cancers

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Antibodies against the B cell-specific antigens CD20 and CD19 have markedly improved the treatment of B cell-derived lymphoma and autoimmune diseases by depleting malignant and autoreactive B cells. However, since CD20 and CD19 are also expressed on healthy B cells, such antibodies lack disease specificity. Here, we optimize a previously developed concept that uses bispecific antibodies to induce apoptosis selectively in malignant and autoreactive B cells that express the death receptor CD95. We describe the development and characterization of bispecific antibodies with CD95xCD20 and CD95xCD19 specificity in a new IgG-based format. We could show that especially the CD95xCD20 antibody mediated a strong induction of apoptosis in malignant B cells in vitro. In vivo, the antibody was clearly superior to the previously used Fabsc format with identical specificities. In addition, both IgGsc antibodies depleted activated B cells in vitro, leading to a significant reduction in antibody production and cytokine secretion. The killing of resting B cells and hepatocytes that lack CD95 and CD20/CD19, respectively, was marginal. Thus, our results imply that bispecific anti-CD95 antibodies in the IgGsc format are an attractive tool for a more selective and efficient depletion of malignant as well as autoreactive B cells.

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Tafasitamab: First Approval

Cited by 24 publications

References 13 publications

FDA-Approved Drugs for Hematological Malignancies—The Last Decade Review

FDA-Approved Drugs for Hematological Malignancies—The Last Decade Review

Monoclonal Antibodies (mAbs) Approved for Cancer Treatment in the 2020s

IgG-Based Bispecific Anti-CD95 Antibodies for the Treatment of B Cell-Derived Malignancies and Autoimmune Diseases

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