On June 18, 2025, the U.S. Food and Drug Administration (FDA) approved a new combination therapy for adults with relapsed or refractory follicular lymphoma (FL). The treatment includes tafasitamab-cxix (Monjuvi) used together with lenalidomide and rituximab. This new approval offers another treatment choice for adults whose follicular lymphoma has returned or not responded to previous therapies.
How Effective Is the Treatment?
The approval was based on results from the inMIND clinical trial, which enrolled 548 patients with relapsed or refractory FL. Patients in the study had typically already received at least one previous treatment. The main goal was to see how long patients lived without their cancer getting worse (progression-free survival, or PFS).
- After a median follow-up of 14.1 months, those who received tafasitamab-cxix with lenalidomide and rituximab had a median PFS of 22.4 months, compared to 13.9 months for those who received the standard treatment.
- The benefit in progression-free survival was observed regardless of how many prior lines of therapy patients had received, making it a valuable option for a broad range of relapsed or refractory follicular lymphoma patients
Safety Information
- Serious side effects occurred in 33% of patients receiving the new combination, with serious infections reported in 24%.
- The prescribing information includes warnings about possible infusion-related reactions, low blood counts (myelosuppression), and infections.
This approval introduces a chemotherapy-free, immune-based triplet regimen. It expands treatment choices for patients who may benefit from alternatives to traditional chemotherapy, which can be especially important for those with relapsed disease or multiple prior treatments.
First Dual CD19 and CD20 Targeted Therapy
This is the first FDA-approved regimen combining CD19- and CD20-targeted immunotherapies (tafasitamab and rituximab, respectively) for follicular lymphoma, potentially offering a new mechanism of action against the disease.
About Monjuvi
Monjuvi MOR208 is a humanized monoclonal antibody precision medicine directed against the CD19 antigen. Monjuvi was approved under accelerated approval by the FDA in 2020 in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
Reference
Sehn L H., et al. ASH Annual Meeting 2024; Late Breaking Abstract Tafasitamab Plus Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma: Results from a Phase 3 Study (inMIND).
