Tafasitamab: First Approval
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ADISINSIGHT REPORT
Tafasitamab: First Approval Sheridan M. Hoy1
© Springer Nature Switzerland AG 2020
Abstract Tafasitamab (tafasitamab-cxix; MONJUVI®) is an Fc-modified (i.e. two amino acid substitutions within the Fc region, resulting in increased Fcγ receptor affinity), humanized, anti-CD19 monoclonal antibody. Developed by MorphoSys AG, under a license from Xencor, it received accelerated approval (in July 2020) for use in combination with lenalidomide as a treatment for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplantation (ASCT). It is the first therapy to be approved as a second-line treatment for this patient population in the USA. The recommended dose of tafasitamab is 12 mg per kg of bodyweight, administered via an intravenous infusion. A regulatory assessment for tafasitamab plus lenalidomide for the treatment of adults with relapsed or refractory DLBCL is currently underway in the EU. Tafasitamab is also being clinically investigated as a therapeutic option in various other B-cell malignancies, including follicular lymphoma and other indolent non-Hodgkin’s lymphoma. This article summarizes the milestones in the development of tafasitamab leading to this first approval for its use in combination with lenalidomide in adults with relapsed or refractory DLBCL.
Tafasitamab (MONJUVI®): Key points An anti-CD19 monoclonal antibody developed by MorphoSys AG, under a license from Xencor, for the treatment of B-cell malignancies Received its first approval on 31 July 2020 in the USA Approved for use in combination with lenalidomide as a treatment for adults with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT
Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.12894974. This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through preclinical and clinical studies to market launch and beyond. * Sheridan M. Hoy [email protected] 1
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand
1 Introduction The prognosis of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following first-line treatment [e.g. with the anti-CD20 monoclonal antibody rituximab in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP)] is poor [1–3]; few salvage regimens are effective and most patients are ineligible for autologous stem cell transplantation (ASCT) owing to age and comorbidities [2]. Targeting antigens other than CD20 may improve outcomes in this patient population [1]. CD19 is an antigen broadly and homogeneously expressed on the surface of normal B cells (from their earliest stage through to maturity) and across various B-cell mali
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