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

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Postmedia has not reviewed the content. by GlobeNewswire Knight Therapeutics Announces Supplemental Regulatory Submission for MINJUVI® (tafasitamab) in BrazilAuthor of the article:MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) — Knight Therapeutics Inc. (“Knight”) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.THIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLYSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman, and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.SUBSCRIBE TO UNLOCK MORE ARTICLESSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.REGISTER / SIGN IN TO UNLOCK MORE ARTICLESCreate an account or sign in to continue with your reading experience.Access articles from across Canada with one account.Share your thoughts and join the conversation in the comments.Enjoy additional articles per month.Get email updates from your favourite authors.THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK.Create an account or sign in to continue with your reading experience.Access articles from across Canada with one accountShare your thoughts and join the conversation in the commentsEnjoy additional articles per monthGet email updates from your favourite authorsSign In or Create an Account“This supplemental submission to ANVISA marks an important step in our efforts to expand MINJUVI®’s potential in earlier lines of therapy in Brazil,” said Samira Sakhia, President and Chief Executive Officer of Knight. “Patients with previously untreated DLBCL and HGBL continue to face significant unmet medical needs. We are encouraged by the clinical data supporting the addition of tafasitamab and look forward to working with regulators under Project Orbis to bring this potential new first-line treatment option to patients as quickly as possible.”Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try againIn September 2021, Knight entered into an exclusive supply and distribution agreement with Incyte (NASDAQ:INCY), for the exclusive rights to distribute tafasitamab (commercialized as MONJUVI® in the United States and MINJUVI® ex-U.S.). Knight has launched MINJUVI® in Brazil, Mexico and Argentina for use in combination with lenalidomide, followed by MINJUVI® monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL, who are not eligible for autologous stem cell transplantation (ASCT). In March 2026, Knight announced the approval and launch of MINJUVI® in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in Brazil.1 Also in March 2026, Knight submitted MINJUVI® for the same indication in Argentina and Mexico.This supplemental submission to ANVISA builds on those approvals, seeking a first-line indication for MINJUVI® based on results from the Phase 3 frontMIND trial.MINJUVI® (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.In the U.S., MONJUVI® is approved for use in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).2Additionally, MONJUVI® received approval in the U.S. in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).2 This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).This advertisement has not loaded yet.This advertisement has not loaded yet, but your article continues below.In Europe, MINJUVI® received conditional marketing authorization from the European Medicines Agency in combination with lenalidomide, followed by MINJUVI®monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Additionally, MINJUVI® is approved for use in Europe in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.3In Japan, MINJUVI® is approved for use in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).4 MINJUVI® is also approved for use in Japan in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory FL (2L+ FL).5XmAb is a registered trademark of Xencor, Inc.MONJUVI® and MINJUVI® are registered trademarks of Incyte. All other trademarks are the property of their respective owners.AboutDiffuse Large B-Cell Lymphoma (DLBCL) Diffuse Large B-Cell Lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide, accounting for a third of all NHLs and ranging between 20%−50% by country.6 DLBCL commonly presents with enlarged lymph nodes or rapidly growing mass along with B symptoms, which include fever, night sweats, and weight loss. The B symptoms can be seen in 30% of patients. Bone marrow involvement is more common in indolent disease and can be seen in up to 50% of the cases.7 Each year, approximately 25,000 people in the U.S. and up to projected 28,000 people in Western Europe are diagnosed with DLBCL.8,9 In Brazil, data from The Department of Information Technology of the Brazilian Public Unified Healthcare System (DataSUS) reported DLBCL as the most frequently diagnosed NHL with 39,012 cases reported between 2008 – 2017. With about 40% of DLBCL patients not responding to initial therapy or relapsing thereafter,10,11 there is a high medical need for new, effective therapies, particularly for high-risk patients.About High-grade B-Cell Lymphoma (HGBL)High-grade B-Cell Lymphoma (HGBL) is a rare and aggressive category of B-cell non-Hodgkin lymphoma (NHL) defined by the World Health Organization (WHO).12 It comprises two principal subtypes based on specific genetic characteristics: DLBCL/HGBL with MYC and BCL2 rearrangements, which encompasses most lymphomas previously known as double- or triple-hit lymphoma, and HGBL, not otherwise specified (NOS), a heterogeneous subtype defined by high-grade morphology in the absence of these genetic rearrangements.12,14 HGBL shares clinical features with DLBCL, including rapidly enlarging lymph nodes and B symptoms such as fever, night sweats, and weight loss, and accurate diagnosis requires expert pathologic review incorporating cytomorphology, immunohistochemistry, and fluorescence in situ hybridization (FISH).12,15 The aggressive nature of HGBL and the failure of intensified therapy to improve overall survival underscore the significant unmet need for more effective treatment options.12,13The frontMIND trial (NCT04824092) is a randomized, double-blind, placebo-controlled, global Phase 3 study in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).16The study enrolled 899 adults (≥18 to ≤80 years) and is evaluating the efficacy and safety of tafasitamab and lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) compared with R-CHOP.16The primary endpoint of the study is investigator-assessed progression-free survival (PFS) using the Lugano 2014 criteria. Key secondary endpoints include event-free survival (EFS) by investigator assessment and overall survival (OS).16For more information about the frontMIND trial, please visit https://www.clinicaltrials.gov/study/NCT04824092.About Knight Therapeutics Inc.Knight Therapeutics Inc., headquartered in Montreal, Canada, is a pharmaceutical company focused on acquiring, in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight’s Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.’s shares trade on the TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company’s web site at https://knighttx.com/ or www.sedarplus.ca.Forward-Looking Statements for KnightThis document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.’s Annual Report and in Knight Therapeutics Inc.’s Annual Information Form for the year ended December 31, 2025, as filed on www.sedarplus.ca. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.MINJUVI (tafasitamab) Powder for solution for infusion 200 mg ANVISA; prescribing information January, 2026. Accessed February 19th 2026.MONJUVI (tafasitamab-cxix) [package insert]. Wilmington, DE: Incyte Corporation; June, 2025. Accessed June 8, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761163s013lbl.pdfMinjuvi (tafasitamab) [summary of product characteristics]. Amsterdam, the Netherlands: Incyte Biosciences Distribution B.V.; January, 2026. Accessed June 8, 2026. https://www.ema.europa.eu/en/documents/product-information/minjuvi-epar-product-information_en.pdfIncyte. Minjuvi® (tafasitamab) Product Information (Japan) and Pharmaceuticals and Medical Devices Agency (PMDA) electronic package insert. Accessed June 2026. https://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html.Biosciences Japan G.K. Incyte Japan announces approval of Minjuvi® (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Incyte. Published June 19, 2026. Accessed July 30, 2026. https://investor.incyte.com/news-releases/news-release-details/incyte-japan-announces-approval-minjuvir-tafasitamab-0Wang SS. Epidemiology and etiology of diffuse large B-cell lymphoma. Semin Hematol. 2023;60(5):255-266. doi:10.1053/j.seminhematol.2023.11.004Padala SA, Kallam A. Diffuse large B-cell lymphoma. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; updated April 24, 2023. Accessed June 8, 2026. https://www.ncbi.nlm.nih.gov/books/NBK557796/Chihara D, Johnston K, Bolatova T, et al. An Epidemiological Model to Estimate the Prevalence of Diffuse Large B-Cell Lymphoma in the United States. Clin Lymphoma Myeloma Leuk. 2022;22(12):e1092-e1099. doi:10.1016/j.clml.2022.08.008Berhan A, Almaw A, Damtie S, Solomon Y. Diffuse large B cell lymphoma (DLBCL): epidemiology, pathophysiology, risk stratification, advancement in diagnostic approaches and prospects: narrative review. Discov Oncol. 2025;16(1):184. Published 2025 Feb 15. doi:10.1007/s12672-025-01958-wMartins DP, Correa-Netto NF, Melo N, Loggetto SR, de Liberal MMC. Overview of lymphoma diagnosis in Brazilian public health system patients: Open data analysis for health care planning. Hematol Transfus Cell Ther. 2022;44(1):40-48. doi:10.1016/j.htct.2020.08.017Sawalha Y. Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Look at the Approved and Emerging Therapies. J Pers Med. 2021;11(12):1345. Published 2021 Dec 10. doi:10.3390/jpm11121345Lymphoma Research Foundation. High-grade B-cell lymphoma. Updated May 2024. Accessed June 19, 2026. https://lymphoma.org/publication/high-grade-b-cell-lymphoma-fact-sheet/Davies AJ. The high-grade B-cell lymphomas: double hit and more. Blood. 2024;144(25):2583-2592. doi:10.1182/blood.2023020780Zayac AS, Landsburg DJ, Hughes ME, et al. High-grade B-cell lymphoma, not otherwise specified: a multi-institutional retrospective study. Blood Adv. 2023;7(21):6381-6394. doi:10.1182/bloodadvances.2023009731Olszewski AJ, Avigdor A, Bachy E, et al. Defining and treating high-grade B-cell lymphoma, NOS. Blood. 2022;140(9):943-954. doi:10.1182/blood.2022016534Lenz G, Trněný M, Burke JM, et al. Tafasitamab plus lenalidomide and R-CHOP versus R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma (frontMIND): a global, phase 3, randomised, double-blind, placebo-controlled trial. Lancet. Published online May 30, 2026. doi:10.1016/S0140-6736(26)00866-4Investor Contact: Knight Therapeutics Inc. Samira SakhiaArvind UtchanahPresident & Chief Executive OfficerChief Financial OfficerT: 514.484.4483T. 514.484.4483Email: IR@knighttx.comEmail: IR@knighttx.comWebsite: www.knighttx.comWebsite: www.knighttx.comNotice for the Postmedia NetworkThis website uses cookies to personalize your content (including ads), and allows us to analyze our traffic. Read more about cookies here. By continuing to use our site, you agree to our Terms of Use and Privacy Policy.