1st July 2025
In June 2025, the U.S. Food and Drug Administration (FDA) approved a new combination treatment option for adults with relapsed or refractory follicular lymphoma (FL).
This combination includes tafasitamab (also known as Monjuvi®, developed by Incyte), rituximab, and lenalidomide — and is now available for eligible patients in the United States.
“While most patients have a good response to initial FL treatment, recurrences can become increasingly difficult for patients to manage as they navigate the next treatment steps related to relapse,” said Dr Mitchell Smith, Chief Medical Officer at the FLF. “We are pleased that the FDA has approved tafasitamab, part of a treatment combination offering a new option for patients living with this chronic disease.”
Tafasitamab is a type of monoclonal antibody, designed to recognize and bind to a protein called CD19, found on the surface of B-cells (the immune cells affected in follicular lymphoma). By attaching to CD19, tafasitamab helps the immune system detect and destroy the lymphoma B-cells.
The treatment is used together with a commonly used combination of two other drugs, often referred to as R2:
This three-drug combination works together to improve the chances of controlling the disease. It is an interesting approach, as it targets both CD19 and CD20, two of the major targets in most T-cell engaging therapies (such as CART, bispecific antibodies and monoclonal antibodies).
The FDA has approved the use of tafasitamab + rituximab + lenalidomide for adults with relapsed or refractory follicular lymphoma, meaning:
This approval provides a non-chemotherapy option for people who have already received at least one prior treatment.
The FDA’s decision was based on results from data from the randomized, double-blind, placebo-controlled Phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab in combination with rituximab and lenalidomide in adult patients with relapsed or refractory FL.
In the inMIND trial, this new drug combination led to improved response rates and progression-free survival (PFS) when compared to rituximab and lenalidomide alone in relapsed or refractory FL. PFS was increased from 14 months to 22 months. The benefit was seen in patients with grades 1 to 3A follicular lymphoma who had received at least one prior systemic treatment.
A key result from the inMIND trial was that the addition of tafasitamab did not significantly increase the level of toxicities in patients, compared to R2 alone. This is especially important when considering that FL patients are likely to go through several lines of treatment during their lifetime and so minimising cumulative toxicities may be of clinical benefit patients.
The most common side effects (greater than 20% of cases) reported from the inMIND study for this new combination in people with relapsed or refractory FL include:
Follicular lymphoma is typically slow-growing but often returns after treatment. This approval adds a new, targeted immunotherapy option not based on chemotherapy that may improve both outcomes and quality of life for patients facing relapse. It also represents a meaningful step toward more personalized treatment in FL.
This FDA approval gives patients with relapsed or refractory FL a new option to discuss with their care team. Hopefully in the coming 1-2 years, we may see approval of the tafasitamab + rituximab + lenalidomide combination in other regions, including the UK, EU, Japan and Australia.
For more information on “When FL returns or changes” click here, and on immunotherapy options in FL (including CAR-T) click here.
To learn more from the experts and people living with FL who have received CAR-T therapy, experienced relapse and for more information on clinical trials, watch our webinars on these important topics.
This article is for information purposes only, and we recommend that you speak with your healthcare team if you have any questions around suitability and regional accessibility of therapy options.
If you have any questions, please get in touch by emailing us at info@theflf.org
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