Knight Therapeutics Announces Regulatory Supplemental Submission of MINJUVI® (tafasitamab) for Follicular Lymphoma in Brazil

Core Viewpoint - Knight Therapeutics Inc. announced a supplemental application to ANVISA for MINJUVI® (tafasitamab) in combination with rituximab and lenalidomide for treating adult patients with previously treated follicular lymphoma in Brazil, highlighting the company's commitment to innovation in cancer treatment [1][4]. Company Overview - Knight Therapeutics Inc. is a pan-American specialty pharmaceutical company focused on acquiring and commercializing pharmaceutical products in Canada and Latin America, with shares trading on TSX under the symbol GUD [11]. Product Information - MINJUVI® (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, designed to mediate B-cell lysis through various immune mechanisms [7]. - The product is already approved in the U.S. in combination with lenalidomide and rituximab for adult patients with relapsed or refractory follicular lymphoma [8]. Regulatory Developments - The supplemental application for MINJUVI® was selected for review under Project Orbis, indicating a streamlined regulatory process for innovative therapies [1]. - The submission is based on results from the pivotal Phase 3 inMIND trial, which showed significant improvements in progression-free survival for patients treated with tafasitamab compared to placebo [6]. Market Context - Follicular lymphoma is the most common indolent form of non-Hodgkin lymphoma, with an expected incidence of 5.57 per 100,000 in the general Brazilian population, and it constitutes 20% to 25% of adult NHL cases [5]. - There are limited treatment options available for relapsed or refractory follicular lymphoma, underscoring the need for new therapeutic options [5].