Knight Therapeutics Announces Launch of Minjuvi in Brazil - Seite 2

“In line with Knight’s commitment to advancing healthcare in Latin America, we are excited to launch Minjuvi in Brazil, an innovative treatment option for addressing a current unmet medical need,” said Samira Sakhia, Knight Therapeutics President and CEO.

“Knight’s team in Brazil is thrilled to make Minjuvi available to health care professionals and centers, improving DLBCL patient care in the country,” said Cristiane Coelho, Knight Therapeutics Brazil General Manager.

About Tafasitamab (Minjuvi)

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. In 2024, Incyte was assigned such license and now exclusively holds such rights. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplantation (ASCT). This indication has received accelerated approval based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of the clinical benefit in confirmatory trial(s). Please see the U.S. full Prescribing Information for Monjuvi for important safety information. 

In Europe, Minjuvi (tafasitamab) received conditional marketing authorization, in combination with lenalidomide, followed by Minjuvi monotherapy, for 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).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. Its safety and efficacy for these investigational indications have not been established in pivotal trials.

Minjuvi and Monjuvi are registered trademarks of Incyte. Tafasitamab is marketed under the brand name Monjuvi in the U.S. and under the brand name Minjuvi in Europe, the United Kingdom and Canada.