The European Commission has approved tafasitamab (Minjuvi) in combination with lenalidomide and rituximab for adult patients with relapsed or refractory follicular lymphoma grade 1-3a after at least one prior systemic therapy.
The approval is based on the phase 3 inMIND trial, which showed statistically significant improvement in progression-free survival with the combination versus lenalidomide and rituximab alone.
“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 at Incyte, according to the press release.
This is the second indication for tafasitamab in Europe.
