Europe Approves Minjuvi, a New Chemotherapy-Free Hope for Lymphoma

WILMINGTON, Del. – December 17, 2025 – The European Commission (EC) has granted a landmark approval for Incyte’s Minjuvi® (tafasitamab), ushering in a new era for patients with a common and incurable form of blood cancer. The decision authorizes Minjuvi in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL), providing the first chemotherapy-free, dual-targeted immunotherapy for this patient population in Europe.

This approval addresses a significant unmet need for individuals whose cancer has returned after at least one prior line of treatment. Follicular lymphoma, the most common slow-growing B-cell non-Hodgkin lymphoma, is characterized by frequent relapses, with treatment options becoming less effective over time.

"The EC approval of Minjuvi addresses a critical need, bringing a new, first-of-its-kind, chemotherapy-free option to patients in Europe with relapsed or refractory FL,” said Bill Meury, President and Chief Executive Officer of Incyte, in a statement. “Historically, FL patients have had limited treatment options in the second-line setting, and we are proud to drive this important advancement for the lymphoma community."

A Clinically Meaningful Leap in Progression-Free Survival

The EC's decision is anchored by compelling results from the global Phase 3 inMIND clinical trial. The study demonstrated that the addition of Minjuvi to the established combination of rituximab and lenalidomide delivered a statistically significant and clinically meaningful improvement in progression-free survival (PFS)—the length of time a patient lives without their disease worsening.

In the trial, patients receiving the Minjuvi-based combination achieved a median PFS of 22.4 months. This represents a substantial extension compared to the 13.9 months observed in the control group, which received a placebo alongside rituximab and lenalidomide. The data translates to a 57% reduction in the risk of disease progression or death for patients treated with the Minjuvi regimen. These benefits were consistent even among high-risk patients, such as those whose disease progressed within 24 months of their first treatment.

“Relapsed or refractory FL is an incurable, complex and persistent cancer,” noted Stefano Luminari, M.D., a study investigator and Professor of Oncology at the University of Modena and Reggio Emilia, Italy. “The EC approval of Minjuvi in combination with lenalidomide and rituximab represents an important innovation, as it brings the first CD19- and CD20-dual-targeted immunotherapy to eligible patients with FL in Europe, which has demonstrated a meaningful reduction in the risk of disease progression.”

The introduction of an effective chemotherapy-free regimen is a crucial development for patients who often endure cumulative toxicities from repeated rounds of traditional chemotherapy. By offering a well-tolerated alternative that significantly delays cancer progression, the new combination therapy has the potential to improve not only survival outcomes but also the quality of life for those living with this chronic malignancy.

The Science of Dual-Targeted Immunotherapy

Minjuvi's success lies in its innovative mechanism of action. It is a humanized monoclonal antibody designed to seek out and attach to CD19, a protein found on the surface of B-cells, which become cancerous in follicular lymphoma. By binding to CD19, Minjuvi flags the cancer cells for destruction by the patient's own immune system.

The therapy's power is amplified by its use in a dual-targeted combination. While Minjuvi targets CD19, the regimen also includes rituximab, a well-established antibody that targets a different surface protein called CD20. By attacking the cancer cells via two distinct pathways, the combination strategy aims to create a more comprehensive and robust anti-tumor response, potentially overcoming mechanisms of resistance that might arise with single-target agents.

Furthermore, Minjuvi incorporates an advanced XmAb® engineered Fc domain, licensed from Xencor, Inc. This modification enhances the antibody's ability to recruit and activate immune effector cells, boosting its cancer-killing capabilities through processes known as Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

Reshaping the European Treatment Landscape

The approval of Minjuvi for use after just one prior therapy strategically positions it within a complex and evolving European treatment landscape. While immunochemotherapy remains a standard approach, the field has been moving toward more targeted and less toxic options. The lenalidomide and rituximab combination (known as R²) was already an established chemotherapy-free option, and Minjuvi's approval builds upon this foundation by significantly improving its efficacy.

This new regimen enters a competitive space that includes advanced treatments like CAR-T cell therapies (e.g., Kymriah, Yescarta, and Breyanzi), which are highly effective but generally reserved for patients who have failed two or more lines of therapy due to their complexity and potential for severe side effects. Minjuvi offers a powerful, more accessible immunotherapy option earlier in the treatment journey.

The field is also anticipating the arrival of bispecific antibodies, which engage both T-cells and cancer cells. Drugs like epcoritamab and odronextamab have shown impressive results in clinical trials and are poised to become major players. However, Minjuvi's approval as the first dual CD19/CD20-targeted combination gives it a distinct and immediate role in clinical practice, providing a new standard of care for a broad population of patients with relapsed follicular lymphoma.

A Key Strategic Win for Incyte

For Wilmington, Delaware-based Incyte, this approval marks a significant commercial and strategic victory. It is the second European indication for Minjuvi, which was previously approved for another type of lymphoma, diffuse large B-cell lymphoma (DLBCL). This success expands the company's oncology footprint in the lucrative European market and strengthens its portfolio of "first-in-class" medicines.

The approval reinforces Incyte's mission to develop innovative solutions for patients with high unmet medical needs. With a growing patient population—projected to exceed 31,000 new cases of follicular lymphoma in major global markets in 2025—the commercial opportunity for an effective second-line therapy is substantial.

The safety profile of the Minjuvi combination was found to be manageable and consistent with the known side effects of its individual components. The most common adverse reactions reported in the inMIND study included infections, neutropenia (low white blood cell count), diarrhea, rash, and fatigue. As with many immunotherapies, careful monitoring for infections and blood cell counts is recommended. The overall benefit-risk profile was deemed highly favorable, paving the way for its adoption by hematologists and oncologists across Europe.