Incyte Announces Positive CHMP Opinion for Minjuvi (tafasitamab) for the Treatment of Relapsed or Refractory Follicular Lymphoma (FL)

Incyte (Nasdaq:INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of 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.

"If approved, Minjuvi in combination with rituximab and lenalidomide will represent the first CD19- and CD20-dual-targeted immunotherapy for patients in Europe living with relapsed or refractory FL," said Lee Heeson, Executive Vice President and Head of Incyte International. "Based on the inMIND clinical trial results, Minjuvi has demonstrated its ability to offer patients improved progression free survival. The positive CHMP opinion is an encouraging step in our ongoing efforts to advance treatments that address critical gaps for patients."

The positive CHMP opinion is based on data from the Phase 3 inMIND trial evaluating the efficacy and safety of Minjuvi in combination with rituximab and lenalidomide in 548 adult patients with relapsed or refractory FL. Results from the trial, featured at the 2024 American Society of Hematology (ASH) Annual Meeting, 2025 European Hematology Association (EHA) Congress and 2025 International Conference on Malignant Lymphoma (ICML), 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<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 Minjuvi group versus 16.0 months (95% CI, 13.9-21.1) in the placebo group (HR: 0.41 [95% CI, 0.29-0.56]).