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].

Core Viewpoint - Genmab A/S plans to submit a supplemental Biologics License Application (sBLA) for subcutaneous epcoritamab in combination with rituximab and lenalidomide for treating adult patients with relapsed or refractory follicular lymphoma in the first half of 2025 [1][3] Company Announcement - The sBLA submission is based on positive topline results from the Phase 3 EPCORE FL-1 trial, which showed that epcoritamab plus rituximab (R) met one of its dual primary endpoints of overall response rate (ORR) with a p-value of less than 0.0001 [2][7] - The safety profile of the combination therapy was consistent with known safety profiles of the individual components, and no new safety signals were observed [2][3] About Follicular Lymphoma (FL) - Follicular lymphoma is a slow-growing form of non-Hodgkin's lymphoma, accounting for 20-30% of all cases, with approximately 15,000 new cases diagnosed annually in the U.S. [4] - It is considered incurable with current standard therapies, and patients often experience shorter remission periods with each relapse [4] About the EPCORE FL-1 Trial - The EPCORE FL-1 trial is a Phase 3 open-label interventional study evaluating the safety and efficacy of epcoritamab plus rituximab and lenalidomide versus rituximab alone in patients with relapsed/refractory follicular lymphoma [5] About Epcoritamab - Epcoritamab is an IgG1-bispecific antibody developed using Genmab's DuoBody technology, designed to target CD3 on T cells and CD20 on B cells, inducing T-cell-mediated killing of CD20+ cells [6][7] - It is currently approved by the FDA as a monotherapy for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy [3][7] Collaboration and Future Plans - Genmab is co-developing epcoritamab with AbbVie, sharing commercial responsibilities in the U.S. and Japan, and both companies are pursuing additional international regulatory approvals for the investigational indication [8][9] - Genmab and AbbVie are also evaluating epcoritamab in various hematologic malignancies across multiple ongoing Phase 3 trials [9]