The European Commission (EC) has approved tafasitamab in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.

"The EC approval of tafasitamab 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, Incyte.

“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 as we seek to deliver innovative medicines for patients with cancer.”

The EC decision follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in November 2025. This marks the second indication for tafasitamab, which was previously approved by the EC in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The EC decision is based on data from the Phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab in combination with rituximab and lenalidomide as a treatment for patients with relapsed or refractory FL. Results from the trial showed that tafasitamab combined with rituximab and lenalidomide met its primary endpoint. The data demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in comparison to placebo added to lenalidomide and rituximab.

Patients receiving tafasitamab in combination with rituximab and lenalidomide achieved a median PFS by investigator assessment of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared to 13.9 months (95% CI, 11.5-16.4) in the control arm (hazard ratio [HR]: 0.43 [95% CI, 0.32-0.58]; P<0.0001). The PFS assessed by an Independent Review Committee (IRC) was consistent with investigator-based results. Median PFS by IRC was not reached (95% CI, 19.3-NE) in the tafasitamab group versus 16.0 months (95% CI, 13.9-21.1) in the placebo group (HR: 0.41 [95% CI, 0.29-0.56].

Tafasitamab was generally well-tolerated, with a manageable safety profile. Safety and tolerability were comparable with the addition of tafasitamab to lenalidomide in combination with rituximab.

The most common adverse reactions in the Phase 3 study (≥20%) in recipients of tafasitamab, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhoea, rash, fatigue, constipation, musculoskeletal pain and cough.2

FL is the most common slow-growing form of B-cell non-Hodgkin lymphoma (NHL), representing about 30% of NHL cases globally. It is considered incurable, with patients frequently relapsing after initial therapy and experiencing a progressively worsening prognosis with each recurrence.

Despite advances in treatment, there remains a significant unmet need for additional options for relapsed or refractory FL, with approximately 2-4 out of every 100,000 people affected in Western countries.

“Relapsed or refractory FL is an incurable, complex and persistent cancer,” said Stefano Luminari, M.D., Professor of Oncology, University of Modena and Reggio Emilia, Italy and inMIND study investigator. “The EC approval of tafasitamab 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, including among those with high-risk disease.”

Source: Inctye