FDA gives nod for Monjuvi combo for second-line relapsed or refractory diffuse large B-cell lymphoma
pharmafile | August 3, 2020 | News story | Sales and Marketing | FDA, Incyte, Monjuvi, morphosys, pharma
The FDA has awarded MorphoSys and Incyte US approval for their Fc-modified cytolytic CD19-targeting monoclonal antibody Monjuvi (tafasitamab-cxix), when used with Lenalidomide.
The therapy is authorise for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma, as a second line treatment in adults who progressed after first-line, a first for the US regulator. The indication covers DLBCL patients whose disease has originating from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
The approval was won with support of data showing that Monjuvi met its main goal in a Phase 2 study, registering a response in 55% of patients overall, a complete response in 37% of patients, and a partial response in 18% of patients, while median duration of response was shown to be 21.7 months.
Incyte CEO Hervé Hoppenot said the approval “helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States.”
Matt Fellows
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