Incyte Gains FDA Approval for Monjuvi® in Follicular Lymphoma Treatment
Friday, June 20, 2025
Incyte has received approval from the U.S. Food and Drug Administration (FDA) for Monjuvi® (tafasitamab-cxix), in combination with rituximab and lenalidomide, for use in adults with relapsed or refractory follicular lymphoma. Monjuvi is a humanised monoclonal antibody that targets the CD19 protein, which is linked to certain blood cancers.
This marks the second FDA approval for Monjuvi and introduces a new immunotherapy approach that targets both CD-19 and CD-20 antigens. The approval is based on results from the inMIND clinical trial, a double-blind, placebo-controlled study that assessed the safety and effectiveness of the Monjuvi combination in patients with relapsed or refractory lymphoma.
The trial met its main objective, showing a significant improvement in progression-free survival (PFS). Among those treated with Monjuvi, 27.5% experienced disease progression or death, compared with 47.6% in the control group. Patients in the Monjuvi group reached a median PFS of 22.4 months, while the control group had a median of 13.9 months. These findings were consistent with assessments by an Independent Review Committee, further supporting the benefits of the therapy.
Safety data from the study of 546 patients showed that 33% experienced serious adverse events, most commonly infections. Fatal events occurred in 1.5% of participants, while the most frequent side effects included respiratory infections, diarrhoea, fatigue, rash, and musculoskeletal pain. Common lab abnormalities were decreased levels of neutrophils and lymphocytes.
Follicular lymphoma, a common form of non-Hodgkin lymphoma, tends to progress slowly but often returns after treatment, requiring several lines of therapy. The approval of Monjuvi as part of a chemotherapy-free regimen offers a new treatment route for patients, particularly those with high-risk disease.
Monjuvi was first approved in 2020 for use with lenalidomide in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for stem cell transplants. Its continued use in this indication depends on confirmation of clinical benefit in further studies. Tafasitamab, the active component in Monjuvi, is also being evaluated in an ongoing trial for first-line treatment in large B-cell lymphoma.
Source: businesswire.com
