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JUNE 20, 2025

FDA Approves Monjuvi for Relapsed or Refractory Follicular Lymphoma

The FDA approved tafasitamab (Monjuvi, Incyte) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).  

Efficacy was evaluated in inMIND, a double-blind, placebo-controlled trial (ClinicalTrials.gov Identifier: NCT04680052) randomizing 548 patients with relapsed or refractory FL to receive tafasitamab or placebo with lenalidomide and rituximab. Patients received a median of one prior line of systemic therapy; 25% and 20% had two and three or