Knight Therapeutics announced that its Argentine affiliate, Laboratorio LKM S.A., and its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V., filed supplemental applications with ANMAT and COFEPRIS on March 17, 2026 for an additional indication of MINJUVI (tafasitamab) in combination with lenalidomide and rituximab for the treatment of relapsed or refractory follicular lymphoma (FL) Grade 1–3a after at least one prior line of systemic therapy.
The submission expands the therapeutic use of MINJUVI, which is licensed to Incyte under an exclusive worldwide agreement signed in September 2021. Incyte has already secured approvals for the combination in the United States (Monjuvi) and Europe (Minjuvi) and recently received approval in Brazil for FL in March 2026. Knight has launched MINJUVI in Brazil, Mexico, and Argentina for diffuse large B‑cell lymphoma (DLBCL) and is now pursuing the FL indication in two additional Latin American markets.
The combination of tafasitamab with lenalidomide and rituximab has demonstrated a 57% reduction in the risk of disease progression, relapse, or death in the Phase 3 inMIND trial, with a median progression‑free survival of 22.4 months versus 13.9 months in the control arm. The trial results support the clinical value of the therapy and underpin the regulatory submissions in Argentina and Mexico.
Regulatory review timelines are expected to be 180 to 240 calendar days for COFEPRIS and a streamlined process for ANMAT, which typically involves several evaluation stages. While the exact approval dates are not yet known, the submissions position Knight to potentially broaden its market share in the FL segment across Latin America, where the prevalence of relapsed or refractory FL is significant and treatment options are limited.
"In past two years we have launched MINJUVI® for the treatment of diffuse large B‑cell lymphoma in Brazil, Mexico, and Argentina. More recently, MINJUVI® received regulatory approval for the treatment of refractory follicular lymphoma in Brazil. We continue to advance our pipeline with the submissions for MINJUVI® in both Argentina and Mexico. More importantly, MINJUVI® is more than a single product," said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics.
The additional indication could strengthen Knight’s competitive positioning against other FL therapies in the region, such as rituximab‑based regimens and emerging CAR‑T cell products, by offering a chemotherapy‑free, antibody‑based option with proven efficacy. The expansion also aligns with Knight’s strategy to build a leading pan‑American specialty pharmaceutical portfolio and to leverage Incyte’s global development pipeline.
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