COFEPRIS Approves Knight's Minjuvi for DLBCL Treatment

Knight Therapeutics, a pan-American specialty pharmaceutical company, announced that its Mexican affiliate, Grupo Biotoscana de Especialidad, has obtained regulatory approval from COFEPRIS, Mexico's health authority, for Minjuvi (tafasitamab) in combination with lenalidomide. This approval applies to 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).

“We are thrilled to announce the approval of Minjuvi, in Mexico, an innovative treatment for adult patients with relapsed or refractory DLBCL. With its novel mechanism of action, Minjuvi offers a new treatment alternative to non-transplant eligible patients who have limited treatment options,” says Samira Sakhia, President and CEO, Knight Therapeutics.

DLBCL is the most common form of non-Hodgkin lymphoma and is characterized by an aggressive clinical profile, according to Knight Therapeutics. While initial treatments can cure many patients, a portion of them may experience a relapse or develop resistance to standard therapies, leaving ASCT as a limited option. For those who are ineligible for ASCT, the prognosis is often poor, highlighting the critical need for alternative treatments.

The approval of Minjuvi in Mexico is based on data from the L-MIND trial, a Phase 2 study that evaluated the use of Minjuvi in combination with lenalidomide. This open-label, multicenter study focused on adult patients with relapsed or refractory DLBCL who could not undergo ASCT. According to the 2024 National Comprehensive Cancer Network Guidelines, Minjuvi is recommended as a second-line treatment for DLBCL patients who are ineligible for transplantation.

Knight Therapeutics aims to launch Minjuvi in Mexico in the first half of 2025. The availability of Minjuvi in Mexico stems from a 2021 agreement between Knight Therapeutics and Incyte, granting Knight Therapeutics the exclusive rights to distribute tafasitamab, marketed as Monjuvi in the United States and Minjuvi in Europe, across Latin America. This partnership aims to broaden access to innovative cancer treatments in the region.