Incyte (INCY) announced that the FDA has approved Monjuvi, tafasitamab-cxix, a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma, or FL. The Priority Review and FDA approval of the supplemental Biologics License Application for Monjuvi was based on data from the pivotal, randomized, double-blind, placebo-controlled Phase 3 inMIND trial evaluating the efficacy and safety of Monjuvi in combination with rituximab and lenalidomide in adult patients with relapsed or refractory FL. Data from the trial was featured in the Late-breaking Session at the 2024 American Society of Hematology Annual Meeting.
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