The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of tafasitamab (Minjuvi)® in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma grade 1-3a after at least one line of systemic therapy.
The positive CHMP opinion is based on data from the phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab in combination with rituximab and lenalidomide in 548 adult patients with relapsed or refractory follicular lymphoma. The trial showed that the treatment reached its primary endpoint and that the treatment was well tolerated, with a manageable safety profile.
Dr. Trněný, a professor of medical oncology at Charles University Hospital in Prague and an investigator on the study, discussed results from the phase 3 inMIND study with SOHO Insider earlier this year.
The FDA approved tafasitamab in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma in June 2025.
