Knight Therapeutics向巴西ANVISA提交MINJUVI(他法西他单抗)一线DLBCL/HGBL适应症补充申请

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 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.”
In 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.
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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.
About MINJUVI
®
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).
2
Additionally, 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).
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.
3
In 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).
5
XmAb 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.
About
Diffuse Large B-Cell Lymphoma (DLBCL)
Diffuse Large B-Cell Lymphoma (DLBCL)
i
s 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
,
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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).
1
2
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.
1
2
,1
4
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).
1
2
,1
5
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.
1
2
,1
3
About frontMIND trial
The 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).
1
6
The 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.
1
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The 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).
1
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For 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 Knight
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, 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.
References
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761163s013lbl.pdf
Minjuvi (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.pdf
Incyte. Minjuvi
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(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
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Biosciences Japan G.K. Incyte Japan announces approval of Minjuvi
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Incyte
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https://investor.incyte.com/news-releases/news-release-details/incyte-japan-announces-approval-minjuvir-tafasitamab-0
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Sawalha Y. Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Look at the Approved and Emerging Therapies.
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https://lymphoma.org/publication/high-grade-b-cell-lymphoma-fact-sheet/
Davies AJ. The high-grade B-cell lymphomas: double hit and more.
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Zayac AS, Landsburg DJ, Hughes ME, et al. High-grade B-cell lymphoma, not otherwise specified: a multi-institutional retrospective study.
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Olszewski AJ, Avigdor A, Bachy E, et al. Defining and treating high-grade B-cell lymphoma, NOS.
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Lenz 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.
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. Published online May 30, 2026. doi:10.1016/S0140-6736(26)00866-4
CONTACT INFORMATION:
Investor Contact:
Knight Therapeutics Inc.
Samira Sakhia
Arvind Utchanah
President & Chief Executive Officer
Chief Financial Officer
T: 514.484.4483
T. 514.484.4483
Email:
IR@knighttx.com
Email:
IR@knighttx.com
Website:
www.knighttx.com
Website:
www.knighttx.com