Knight Therapeutics announces approval of Minjuvi in Mexico

Knight Therapeutics announced that its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V. has obtained regulatory approval by COFEPRIS, the Mexican health regulatory agency, for Minjuvi in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, who are not eligible for autologous stem cell transplantation. DLBCL is the most common subtype of non-Hodgkin lymphoma, presenting an aggressive clinical profile. While a significant number of patients can be cured with standard front-line therapy, many will develop refractory disease or relapse following an initial response, and these individuals are often ineligible for ASCT. Such patients face a very poor prognosis, emphasizing the need for treatment options to improve their outcomes. The approval is based on the data from L-MIND trial, an open label, multicenter, single arm Phase 2 study, that evaluated Minjuvi in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL ineligible for ASCT. The study primary analysis results demonstrated an objective response rate of 60%, including a complete response rate of 43% and a disease control rate of 74%. According to the 2024 National Comprehensive Cancer Network Guidelines, Minjuvi is listed as one of the preferred second-line treatments for DLBCL patients who are ineligible for transplantation.