FDA approves Monjuvi (tafasitamab-cxix) in combination with lenalidomide for treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (DLBCL)

Approval of this humanised Fc-modified cytolytic CD19 targeting monoclonal antibody was based on data from an open label, single arm phase 2 L-MIND study in combination with lenalidomide, which showed overall response rate of 55% (primary endpoint).

SPS commentary:

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide. Tafasitamab was filed for approval in EU in May 2020 for treatment of relapsed or refractory DLBCL after up to two prior lines of therapy.

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