Following this approval, Knight expects to launch Minjuvi in Brazil in Q2 2024.
In July this year, Agência Nacional de Vigilância Sanitária (ANVISA) granted market authorisation under the rare disease designation.
This authorisation was given as per the Resolution RDC 205/2017 to Minjuvi along with lenalidomide followed by Minjuvi monotherapy for treatment of adults who are not eligible for autologous stem cell transplantation, and with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) including DLBCL occurring from low grade lymphoma.
The approval is based on the data from the Phase II L-MIND study. This single arm, multicentre, open label study evaluated Minjuvi along with lenalidomide in adults with relapsed or refractory DLBCL.
An objective response rate (ORR, primary endpoint) of 60% including a complete response rate (CR) of 43% and a disease control rate (DCR) of 75% were demonstrated in the primary analysis of the study.
Knight Therapeutics president and CEO Samira Sakhia said: “We’re excited to continue to advance the approval of Minjuvi in Brazil, a new treatment option for a current unmet need.
“We look forward to launching Minjuvi in Brazil and obtaining approval in other key markets in Latin America.”
Knight also signed a supply and distribution agreement with Incyte in September 2021 for the exclusive distribution of pemigatinib (Pemazyre) and tafasitamab in Latin America.
Tafasitamab is sold as Minjuvi in Europe and Monjuvi in the US.
Knight Therapeutics Brazil general manager Cristiane Coelho said: “Knight’s team is working diligently with physicians, key institutions and payors to ensure patients have access to Minjuvi.”