Fc-engineered CD19 Antibody Approved for Follicular Lymphoma
The FDA has approved tafasitamab-cxix for certain patients with follicular lymphoma.
The U.S. Food and Drug Administration (FDA) has approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) and rituximab (Rituxan) for the treatment of adult patients with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma.
Tafasitamab-cxix is a targeted antibody designed to bind the CD19 protein that is expressed ubiquitously on B cells, including on the cancerous B cells that make up follicular lymphomas. The tail end of the antibody, known as the Fc region, is modified to improve its ability to interact with immune cells and promote immune-mediated elimination of cancer cells. This is the second FDA approval for tafasitamab-cxix, which had been previously approved for certain patients with diffuse large B-cell lymphomas, another type of non-Hodgkin lymphoma.
Lenalidomide is an immunomodulatory drug that can enhance immune cell activity and lead to cancer cell death. Rituximab is a targeted antibody designed to bind the CD20 protein that is expressed on many B cells, including follicular lymphoma cells.
The latest approval is based on results from the double-blind, placebo-controlled, randomized phase III inMIND trial involving 548 patients with relapsed or refractory follicular lymphoma who had been previously treated with a CD20-directed antibody therapy, such as rituximab. Patients were treated with lenalidomide and rituximab and randomly assigned (1:1) to also receive tafasitamab-cxix or placebo.
With a median follow-up of 14.1 months, patients in the tafasitamab-cxix group were 57% less likely to experience disease progression compared with those in the placebo group. Half of the tafasitamab-cxix-treated patients remained progression-free for at least 22.4 months versus 13.9 months for those in the placebo arm.
The recommended dose for tafasitamab-cxix is 12 mg/kg administered via intravenous infusion for no more than 12 cycles with lenalidomide and rituximab.
Follicular lymphoma is a form of non-Hodgkin lymphoma that arises in B cells (a type of immune cell) within lymph nodes. According to federal statistics, it was estimated that 80,350 individuals would be diagnosed with non-Hodgkin lymphoma and approximately 19,390 patients would die of the disease in the United States in 2025.
The FDA rendered its decision on June 18, 2025. Check this resource for updated information on all therapeutics regulated by the FDA.