Wilmington, DE June 18, 2025. In a significant breakthrough in cancer treatment, the U.S. Food and Drug Administration (FDA) has approved Monjuvi (tafasitamab-cxix), a CD19-directed monoclonal antibody, in combination with rituximab and lenalidomide, to treat adult patients with relapsed or refractory follicular lymphoma (FL). This marks the first FDA-approved therapy targeting both CD19 and CD20 simultaneously, offering these patients a new hope against this slow-growing yet recurring malignancy.
The approval follows the promising results of the global Phase 3 randomized, double-blind inMIND trial, which included 654 participants aged ≥18 years with relapsed or refractory FL or marginal zone lymphoma after first-line treatment. The study indicated that progression-free survival (PFS) improved significantly in patients receiving the combination therapy. Specifically, 27.5% of patients in the Monjuvi arm experienced disease progression or death, compared to 47.6% in the control group. Investigator-based analysis demonstrated a median PFS of 22.4 months in the Monjuvi group versus 13.9 months in the placebo group. These findings were corroborated by an independent review committee.
This represents a second approval of Monjuvi in the U.S., following its initial approval in 2020, for use in combination with lenalidomide in diffuse large B-cell lymphoma (DLBCL). This new approval also defines tafasitamab in this malignancy of B-cell therapy, which means a chemotherapy-free path or available treatment with the potential to provide long-term control.
Safety considerations were carefully evaluated. Of the 546 patients assessed during an inMIND study, 33% experienced severe adverse events, with coronavirus disease 2019 (COVID-19) and pneumonia being the most common infections. Other complications included renal failure, alternative cancers, and febrile neutropenia. A small number of deaths were attributed to overwhelming infections and preexisting conditions. The most frequently reported adverse effects were tiredness, skin rash, gastrointestinal reactions, muscle or joint pain, and respiratory symptoms.
Tafasitamab is developed by MorphoSys and licensed from Xencor. Its engineered Fc region is expected to increase immune-mediated tumor cell killing through the antibody-dependent cell-mediated cytotoxicity (ADCC) and the antibody-dependent cellular phagocytosis (ADCP) mechanisms. It is being developed and commercialized by Incyte, which obtained exclusive worldwide rights in 2024.
The PET-based complete response and the overall survival measures were other important secondary outcomes studied in the inMIND trial and are still under analysis. The trial outcomes demonstrated consistent results across patient subgroups, including those previously treated with multiple lines of therapy.
As follicular lymphoma may account for up to 30% of non-Hodgkin lymphoma cases, with a remission-relapse pattern, maintaining durable disease control is critical. This dual-targeted therapy addresses a significant unmet need for an effective and tolerable option in patients who are ineligible for intensive chemotherapy or stem cell transplantation.
Through its IncyteCARES initiative, Incyte continues to provide comprehensive patient support, making its treatments and educational resources accessible to eligible patients. This new approval gives oncologists a validated, novel option to manage this persistent disease and improve the long-term outcomes of patients across various stages of treatment.
References: Incyte Corporation. FDA approval of Monjuvi® (tafasitamab-cxix) in combination with rituximab and lenalidomide for patients with relapsed or refractory follicular lymphoma. Published June 18, 2025. https://www.incyte.com/newsroom
