Incyte (INCY) announced that the U.S. Food and Drug Administration has approved Monjuvi® (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, for use in combination with rituximab and lenalidomide.
This approval is for treating adult patients with relapsed or refractory follicular lymphoma.
The study evaluated efficacy and safety of Monjuvi combined with rituximab and lenalidomide in adult patients with relapsed or refractory follicular lymphoma.
The trial achieved its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival as assessed by investigators.
Safety was assessed in 546 participants, with serious adverse reactions reported in 33% of those treated with Monjuvi alongside rituximab and lenalidomide.
