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

MONTREAL, March 17, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Argentine affiliate, Laboratorio LKM S.A., and its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V., have submitted a supplemental application to ANMAT, the Argentinian health regulatory agency, and COFEPRIS, the Mexican health regulatory agency, respectively, seeking approval for an additional indication for MINJUVI^® (tafasitamab), in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1–3a) after at least one prior line of systemic therapy.

Knight entered into an exclusive supply and distribution agreement with Incyte (NASDAQ: INCY) in September 2021 for tafasitamab (commercialized as MONJUVI^® (tafasitamab-cxix) in the United States and MINJUVI^® ex-USA) across Latin America. 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 diffuse large B-cell lymphoma (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 FL in Brazil.¹

“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,” said Samira Sakhia President and Chief Executive Officer of Knight Therapeutics. “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. With approvals across distinct indications, it effectively represents multiple therapies within one brand, expanding the ways physicians can use MINJUVI^® to address different patient needs. I am proud of the progress we have made with MINJUVI^® and look forward to continuing our mission to bring high-quality pharmaceuticals that improve patients’ health in our markets.”

About MINJUVI^® (tafasitamab)

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 by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

MONJUVI is not approved and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Additionally, MONJUVI received accelerated approval in the United States and Canada 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).

In Europe, MINJUVI (tafasitamab) 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 in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy in Europe.

In Japan, MINJUVI is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

In Brazil, MINJUVI is approved for use in combination with lenalidomide followed by MINJUVI^® monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma in Brazil, who are not eligible for autologous stem cell transplantation (ASCT) and is also approved in MINJUVI^®, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). MINJUVI is not approved and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

XmAb^® is a registered trademark of Xencor, Inc.

MONJUVI and MINJUVI are registered trademarks of Incyte.

About Follicular Lymphoma (FL)

FL is the most common subtype of indolent non-hodgkin lymphoma (NHL).^2-4 FL typically presents with generalized painless lymphadenopathy that waxes and wanes. It commonly affects the axillary, cervical, femoral, and inguinal lymph nodes. Rarely, it may appear as an asymptomatic large mediastinal mass. Roughly 20% of FL patients experience B symptoms such as night sweats, fever, and weight loss.⁵ Although patients usually respond to initial therapy, FL will typically relapse over time and is therefore considered incurable.^6,7 Approximately a quarter of FL patients are refractory to first-line immunochemotherapy.⁸ Additionally, there is a risk of histologic transformation to DLBCL or high-grade B-cell lymphomas, which occurs at an estimated annual rate of 2% to 3% and is generally associated with a poor clinical outcomes.^9-12

About inMIND Study

The inMIND study (INCMOR 0208-301) was a Phase 3, randomized, double-blind, placebo-controlled, multicenter study in participants with relapsed/refractory FL or relapsed/refractory marginal zone lymphoma (MZL) who had been previously treated with at least one prior line of systemic therapy, including an anti-CD20 antibody. Patients were randomized to receive either tafasitamab + R2 (n = 273) versus placebo + R2 (n = 275). The estimated median progression free survival (PFS; primary endpoint) was 22.37 months (95% CI: 19.22, NE) in the tafasitamab + R2 group compared with 13.93 months (95% CI: 11.53, 16.39) in the placebo + R2 group, with a HR of 0.434 (95% CI: 0.324, 0.580) and a p < 0.0001. Overall, adding tafasitamab to lenalidomide plus rituximab led to a statistically significant, clinically meaningful improvement in PFS, corresponding to a 57% lower risk of progression, relapse, or death in patients with relapsed/refractory follicular lymphoma.¹³ The most common adverse reactions (≥ 20%) in patients with relapsed or refractory FL were respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough. The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) were decreased neutrophils and decreased lymphocytes.¹⁴

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or 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 TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca.

Forward-Looking Statements

This 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, 2024, 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.

References:

1. MINJUVI (tafasitamab) Powder for solution for infusion 200 mg ANVISA; prescribing information January, 2026. Accessed February 19th 2026. https://consultas.anvisa.gov.br/#/bulario/q/?nomeProduto=minjuvi
2. Kanters S, Ball G, Kahl B, et al. Clinical outcomes in patients relapsed/refractory after ≥2 prior lines of therapy for follicular lymphoma: a systematic literature review and meta-analysis. BMC Cancer 2023;23:74. Merryman RW, Rutherford SC, et al. Consensus recommendations from the 2024 International Follicular Lymphoma Scientific Workshop. Blood Adv 2025;:bloodadvances.2025018079. Available at: doi:10.1182/bloodadvances.2025018079
3. Smith SM, Salles G. Indolent lymphomas: introduction to a series highlighting progress and ongoing challenges. Haematologica 2022;107:4-6.
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6. Dreyling M, Ghielmini M, Rule S, et al. Newly diagnosed and relapsed follicular lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2021;32:298-308.
7. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas. Version 2.2025. Published February 10, 2025. Accessed December 5, 2025. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf NCCN
8. Jurczak W. Treatment of high-risk follicular lymphoma. Hemasphere 2019;3(Suppl):85-87.
9. Al-Tourah AJ, Gill KK, Chhanabhai M, et al. Population-based analysis of incidence and outcome of transformed non-Hodgkin's lymphoma. J Clin Oncol 2008;26:5165-5169.
10. Conconi A, Ponzio C, Lobetti-Bodoni C, et al. Incidence, risk factors and outcome of histological transformation in follicular lymphoma. Br J Haematol 2012;157:188-196.
11. Freedman A, Jacobsen E. Follicular lymphoma: 2020 update on diagnosis and management. Am J Hematol 2020;95:316-327.
12. Link BK, Maurer MJ, Nowakowski GS, et al. Rates and outcomes of follicular lymphoma transformation in the immunochemotherapy era: a report from the University of Iowa/Mayo Clinic Specialized Program of Research Excellence Molecular Epidemiology Resource. J Clin Oncol 2013;31:3272-3278.
13. Sehn LH, Luminari S, Scholz CW, Hübel K, Salar A, Paneesha S, Wahlin BE, Panayiotidis P, Lee HP, Jiménez Ubieto A, Sancho JM, Kim TM, Domingo Domenech E, Kumode T, Poh C, Thieblemont C, Deeren D, de Wit E, Arbushites M, Casadebaig ML, Trneny M. Tafasitamab plus lenalidomide and rituximab for relapsed or refractory follicular lymphoma: results from a phase 3 study (inMIND). Blood. 2024;144(suppl 2):LBA-1. doi:10.1182/blood-2024-212970.
14. Incyte Corporation. MONJUVI (tafasitamab-cxix) for injection, for intravenous use prescribing information. Wilmington, DE: Incyte Corporation; June 2025. Accessed December 5, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761163s013lbl.pdf

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