04:47 AM EST, 11/17/2025 (MT Newswires) -- Incyte ( INCY ) said Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion and recommended the approval of its therapy Minjuvi in combination with lenalidomide and rituximab for the treatment of adults with relapsed or refractory follicular lymphoma after at least one line of systemic therapy.
The recommendation is now under review by the European Commission, the company said.
The positive opinion is based on data from a 548-patient phase 3 trial showing that the drug combination met its primary endpoint of significantly improving progression-free survival in comparison with a placebo added to lenalidomide and rituximab, the company said.
The drug combination was also well tolerated, the company said, with a "manageable" safety profile.
Follicular lymphoma is a common slow-growing form of B-cell non-Hodgkin lymphoma, Incyte ( INCY ) said.