Press release
Knight Therapeutics Announces Regulatory Supplemental Submission of MINJUVI® (tafasitamab) for Follicular Lymphoma in Brazil
MONTREAL, July 31, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company,
About this update from Incyte Corporation
[{"type":"text","content":"MONTREAL, July 31, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) (\"Knight\") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltda., has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with rituximab and lenalidomide for the treatment of adult patients with previously treated follicular lymphoma (FL). The supplemental application for the additional indication was selected for review under Project Orbis. In September 2021, Knight entered into an exclusive supply and distribution agreement with Incyte (NASDAQ:INCY), for the exclusive rights to distribute tafasitamab (sold as MONJUVI® in the United States and MINJUVI® outside of the U.S.), as well as PEMAZYRE® (pemigatinib), in Latin America. In February 2024, Knight announced the launch of MINJUVI® in Brazil in combination with lenalidomide followed by MINJUVI® monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). “This regulatory submission for a new indication for tafasitamab in relapsed or refractory FL highlights our steadfast commitment to bringing innovation and enhancing quality of life and care,” said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics. “If approved, the combination of tafasitamab, rituximab and lenalidomide will be an important new therapeutic option for eligible adult patients with previously treated FL in Brazil. We look forward to continuing to work towards regulatory submissions in additional countries in Latin America over the next months.” About Follicular Lymphoma (FL) and inMIND Study FL is the most common indolent, or slow growing, form of non-Hodgkin lymphoma (NHL).1 In Brazil, according to the 2023 data from the National Cancer Institute (INCA) Registries, the expected incidence/year of NHL (inclusive of all subtypes) was 5.57 per 100, 000 in the general population, 6.42 per 100,000 in the male population, and 5.62 per 100,000 in the female population. It is expected that follicular lymphoma constitutes 20% to 25% of adult NHL cases.2...