The Brazilian Health Regulatory Agency (ANVISA) approved tafasitamab (MINJUVI) in combination with rituximab and lenalidomide. This chemotherapy-free triplet regimen is indicated for adult patients with relapsed or refractory follicular lymphoma (FL) grade 1 to 3a after at least one prior systemic therapy.
The review was conducted under Project Orbis, an international partnership allowing for concurrent submission and review of oncology products. Knight Therapeutics distributes the therapy in Latin America under an exclusive 2021 agreement with Incyte, the manufacturer of the therapy.
Beyond this new indication, the drug is already approved in Brazil and the European Union for relapsed or refractory diffuse large B-cell lymphoma, according to the press release by Knight Therapeutics.
This decision follows similar approvals by the FDA and the European Commission.
