- Minjuvi® (tafasitamab) in combination with lenalidomide and rituximab is the first CD19- and CD20-dual-targeted immunotherapy combination regimen approved for eligible patients in Europe with relapsed or refractory FL
- Patients with relapsed or refractory FL achieved significantly improved progression-free survival with Minjuvi in combination with rituximab and lenalidomide in the Phase 3 inMIND registration trial
- In Western countries, including Europe, relapsed or refractory FL affects 2-4 out of every 100,000 people1
WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Minjuvi® (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 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, 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 Minjuvi, 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 Minjuvi in combination with rituximab and lenalidomide as a treatment for patients with relapsed or refractory FL. Results from the trial showed that Minjuvi 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 Minjuvi 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