Core Viewpoint - Knight Therapeutics Inc. announced that its Brazilian affiliate, United Medical Ltda., received approval from ANVISA for an additional indication for MINJUVI® (tafasitamab) in combination with rituximab and lenalidomide for treating adult patients with relapsed or refractory follicular lymphoma (FL) [1][2]. Company Overview - Knight Therapeutics Inc. is a pan-American specialty pharmaceutical company focused on acquiring, in-licensing, and commercializing pharmaceutical products for Canada and Latin America [13]. - The company has an exclusive supply and distribution agreement with Incyte for tafasitamab across Latin America, having launched MINJUVI® in Brazil, Mexico, and Argentina [3]. Product Information - MINJUVI® (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody that mediates B-cell lysis through various immune mechanisms [4]. - The approval in Brazil allows for MINJUVI® to be used in combination with lenalidomide followed by MINJUVI® monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) [9]. Regulatory Approval - The approval from ANVISA is part of Project Orbis, which aims to expedite the review of cancer therapies [1][3]. - MINJUVI® has received various approvals globally, including in the U.S. and Europe, for treating relapsed or refractory FL and DLBCL [5][7][8]. Clinical Study Results - The inMIND study demonstrated that adding tafasitamab to lenalidomide and rituximab significantly improved progression-free survival (PFS) in patients with relapsed/refractory FL, with a median PFS of 22.37 months compared to 13.93 months for the placebo group [12].

Core Viewpoint - Knight Therapeutics Inc. is advancing its MINJUVI® (tafasitamab) product line by seeking additional regulatory approvals in Argentina and Mexico for the treatment of relapsed or refractory follicular lymphoma, expanding its therapeutic applications in Latin America [1][2]. Company Overview - Knight Therapeutics Inc. is a specialty pharmaceutical company based in Montreal, Canada, focused on acquiring and commercializing pharmaceutical products for Canada and Latin America [11]. - The company operates through its Latin American subsidiaries, including United Medical, Biotoscana Farma, and Laboratorio LKM [11]. Product Development - MINJUVI® (tafasitamab) is a humanized monoclonal antibody targeting CD19, designed to mediate B-cell lysis through various immune mechanisms [3]. - The product has received regulatory approvals in multiple regions, including Brazil, Mexico, Argentina, Europe, and Japan, for various indications related to lymphoma treatment [2][6][7]. Recent Regulatory Actions - Knight's Argentine and Mexican affiliates have submitted supplemental applications to their respective health regulatory agencies for MINJUVI® in combination with lenalidomide and rituximab for treating adult patients with relapsed or refractory follicular lymphoma [1]. - The company has successfully launched MINJUVI® in Brazil for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma [2]. Clinical Study Insights - The inMIND study demonstrated that adding tafasitamab to lenalidomide and rituximab significantly improved progression-free survival in patients with relapsed or refractory follicular lymphoma, indicating a 57% lower risk of progression, relapse, or death [10].

Core Viewpoint - Knight Therapeutics Inc. has launched MINJUVI® in Argentina, marking a significant step in expanding access to innovative therapies for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT) [1][5]. Company Summary - Knight Therapeutics Inc. is a pan-American specialty pharmaceutical company focused on acquiring and commercializing pharmaceutical products in Canada and Latin America [11]. - The company has entered into a supply and distribution agreement with Incyte for the exclusive rights to distribute tafasitamab (MINJUVI®) in Latin America [6]. - The launch in Argentina is the third country launch for MINJUVI® in Latin America, reflecting the company's commitment to improving treatment options for patients [5]. Product Summary - MINJUVI® (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, designed to treat adult patients with relapsed or refractory DLBCL [7]. - The approval for MINJUVI® in Argentina is based on the L-MIND trial, which showed an objective response rate (ORR) of 60%, with a complete response rate (CR) of 43% and a disease control rate (DCR) of 74% [3]. - MINJUVI® is recognized as a preferred second-line treatment for DLBCL patients who are ineligible for transplantation according to the 2024 National Comprehensive Cancer Network (NCCN) Guidelines [3]. Industry Context - DLBCL is the most common subtype of non-Hodgkin lymphoma, characterized by an aggressive clinical profile, with many patients developing refractory disease or relapsing after initial treatment [2]. - There is a significant need for new treatment options for patients facing poor prognoses due to the limitations of existing therapies [2].