Knight Therapeutics Submits Supplemental Application to ANVISA for First-Line MINJUVI (tafasitamab) in DLBCL and HGBL
核心洞察
Knight Therapeutics submitted a supplemental application to ANVISA seeking approval for MINJUVI (tafasitamab) plus lenalidomide added to R-CHOP as first-line treatment for previously untreated DLBCL and HGBL.
The supplemental application was selected for review under Project Orbis, reflecting a coordinated regulatory pathway across participating agencies.
The submission builds on results from the Phase 3 frontMIND trial, which enrolled 899 adults and evaluated tafasitamab plus lenalidomide added to R-CHOP versus R-CHOP alone.
Knight Therapeutics Inc. (搜索) (TSX: GUD), a pan-American (ex-US) pharmaceutical company headquartered in Montreal, Canada, announced on August 27, 2026 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 (搜索) (DLBCL) or high-grade B-cell lymphoma (搜索) (HGBL). The supplemental application 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."
Mechanism of Action and Existing Approvals
MINJUVI (tafasitamab) is a humanized Fc-modified cytolytic CD19 (搜索)-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanisms 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.
The supplemental submission builds on a series of prior regulatory milestones. 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 (搜索) (FL) in Brazil, and also submitted MINJUVI for the same indication in Argentina and Mexico.
In the U.S., MONJUVI is approved in combination with lenalidomide and rituximab for relapsed or refractory FL, and in combination with lenalidomide for relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, in patients not eligible for ASCT. The DLBCL indication is approved under accelerated approval based on overall response rate, with continued approval contingent upon verification of clinical benefit in confirmatory trials. In Europe, MINJUVI received conditional marketing authorization from the European Medicines Agency in combination with lenalidomide followed by monotherapy for relapsed or refractory DLBCL, and is also approved in combination with lenalidomide and rituximab for relapsed or refractory FL (Grade 1-3a). In Japan, MINJUVI is approved in combination with lenalidomide for relapsed or refractory DLBCL, and in combination with rituximab and lenalidomide for relapsed or refractory FL (2L+ FL).
The frontMIND Trial
The supplemental submission to ANVISA is based on results from the Phase 3 frontMIND trial (NCT04824092), a randomized, double-blind, placebo-controlled, global Phase 3 study in patients with previously untreated high-risk DLBCL and HGBL. The study enrolled 899 adults (aged 18 to 80 years) and evaluated the efficacy and safety of tafasitamab and lenalidomide added to R-CHOP compared with R-CHOP alone.
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).
Disease Burden and Unmet Need
Diffuse large B-cell lymphoma (搜索) is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide, accounting for a third of all NHLs and ranging between 20% and 50% by country. DLBCL commonly presents with enlarged lymph nodes or a rapidly growing mass along with B symptoms, which include fever, night sweats, and weight loss; 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 cases. Each year, approximately 25,000 people in the U.S. and up to a projected 28,000 people in Western Europe are diagnosed with DLBCL. 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 and 2017. With about 40% of DLBCL patients not responding to initial therapy or relapsing thereafter, there is a high medical need for new, effective therapies, particularly for high-risk patients.
High-grade B-cell lymphoma (搜索) is a rare and aggressive category of B-cell NHL defined by the World Health Organization (WHO). 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. HGBL shares clinical features with DLBCL, including rapidly enlarging lymph nodes and B symptoms, and accurate diagnosis requires expert pathologic review incorporating cytomorphology, immunohistochemistry, and fluorescence in situ hybridization (FISH). 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.