Knight Therapeutics Inc. has officially launched Minjuvi® (tafasitamab) in Mexico through its local affiliate, Grupo Biotoscana de Especialidad S.A. de C.V. The therapy is approved for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT).
The treatment regimen consists of Minjuvi in combination with lenalidomide, followed by Minjuvi monotherapy. This launch represents a significant advancement for Mexican patients with this aggressive form of non-Hodgkin lymphoma who have limited treatment options after failing first-line therapy.
Clinical Evidence Supporting Approval
The Mexican regulatory approval was based on results from the L-MIND trial, an open-label, multicenter, single-arm Phase 2 study. The trial evaluated Minjuvi in combination with lenalidomide for adult patients with relapsed or refractory DLBCL who were ineligible for ASCT.
Key findings from the study's primary analysis demonstrated:
- 60% objective response rate (primary endpoint)
- 43% complete response rate
- 74% disease control rate
Long-term follow-up data showed that approximately 57% of responding patients remained in remission at 5 years, highlighting the durability of response with this regimen.
Dr. Luis Mario Villela, head of clinical hematology and blood bank at CMDRICH Hospital and head of Lymphoma and Myeloma at Ocaranza ISSSTE Hospital in Hermosillo, Sonora, Mexico, commented on the significance of this approval: "The treatment of DLBCL has significantly evolved in recent years, particularly in the relapse/refractory setting. I am glad to have more tools for our patients, as half of those who relapse after first-line therapy are not candidates for autologous transplantation. For these patients, there are new and effective options including Minjuvi, achieving high rates of long-lasting responses."
Dr. Villela also emphasized the favorable safety profile of the regimen, noting that "as a chemo-free regimen, the toxicity is low-grade and manageable."
Addressing an Unmet Medical Need
DLBCL is the most common subtype of non-Hodgkin lymphoma and presents with an aggressive clinical profile. While many patients respond to standard front-line therapy, a significant number develop refractory disease or relapse following initial treatment. These patients, particularly those ineligible for ASCT, face a poor prognosis and limited therapeutic options.
The 2025 National Comprehensive Cancer Network (NCCN) Guidelines now list Minjuvi as one of the preferred second-line treatments for DLBCL patients who are ineligible for transplantation, underscoring its clinical importance in this setting.
Mechanism of Action and Development
Minjuvi is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. It incorporates an XmAb® engineered Fc domain that mediates B-cell lysis through multiple mechanisms:
- Apoptosis
- Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC)
- Antibody-Dependent Cellular Phagocytosis (ADCP)
The drug was originally licensed by MorphoSys from Xencor, Inc. in 2010. In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to develop and commercialize tafasitamab globally. This was followed by a February 2024 agreement granting Incyte exclusive global rights to the drug.
Expanding Access Across Latin America
Knight Therapeutics secured the exclusive rights to distribute tafasitamab in Latin America through a supply and distribution agreement with Incyte in September 2021. The Mexican approval came in October 2024, when COFEPRIS, the Mexican health regulatory agency, granted regulatory approval through orphan medicine recognition.
Samira Sakhia, President and CEO of Knight Therapeutics, expressed enthusiasm about the launch: "Minjuvi is an innovative product presenting clinically meaningful data in DLBCL and with exciting data in other rare lymphomas. We are thrilled to launch in another country and look forward to launching this product in additional markets in Latin America."
Regulatory Status in Other Markets
Tafasitamab has already received regulatory approvals in other major markets:
- In the United States, it is marketed as Monjuvi® and received accelerated approval from the FDA for use in combination with lenalidomide for adult patients with relapsed or refractory DLBCL who are not eligible for ASCT
- In Europe, Minjuvi received conditional Marketing Authorization from the European Medicines Agency for the same indication
The Mexican launch represents Knight Therapeutics' ongoing commitment to bringing innovative oncology therapies to patients throughout Latin America, addressing significant unmet needs in the treatment of aggressive hematologic malignancies.
