Knight Therapeutics Submits Tafasitamab for Approval in Brazil
Knight Therapeutics' Brazilian affiliate has filed a marketing authorization application for tafasitamab with ANVISA, the Brazilian health regulatory agency. The drug is intended for use in combination therapy.
Montreal, Canada – Knight Therapeutics Inc. announced on October 6, 2022, that its Brazilian affiliate, United Medical Ltd., has submitted a marketing authorization application for tafasitamab to ANVISA, the Brazilian health regulatory agency.
The submission seeks approval for tafasitamab in combination with lenalidomide 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).
In September 2021, Knight Therapeutics entered into an exclusive supply and distribution agreement with Incyte for the rights to distribute tafasitamab (marketed as Monjuvi® in the U.S. and Minjuvi® in Europe) and pemigatinib across Latin America.
Samira Sakhia, President and CEO of Knight Therapeutics, stated that upon approval, the combination therapy will offer an important new treatment option for eligible DLBCL patients in Brazil. The company plans to continue its work with Incyte and pursue regulatory submissions in additional Latin American countries.