TAF-DR-RD-278 Clinical Considerations Table 15.09.20.PNG (51.78 kB)

Tafasitamab: First Approval

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posted on 14.09.2020 by Sheridan M. Hoy
Declarations
Funding The preparation of this review was not supported by any external funding.
Authorship and Conflict of interest Sheridan Hoy is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All
authors contributed to the review and are responsible for the article content.
Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.

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.

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