Knight Therapeutics Inc., (TSX:GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltda. has received approval from ANVISA, the Brazilian health regulatory agency, for an additional indication for MINJUVI® (tafasitamab). The approval follows a supplemental regulatory filing and review by ANVISA under Project Orbis for MINJUVI®, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). 1

The approval is supported by data from clinical studies evaluating MINJUVI® in combination with rituximab and lenalidomide (R2), which demonstrated meaningful response rates and durable disease control in patients with previously treated FL.

Knight entered into an exclusive supply and distribution agreement with Incyte (NASDAQ:INCY) in 2021 for tafasitamab (commercialized as MONJUVI® (tafasitamab-cxix) in the United States and MINJUVI® ex-USA) across Latin America. Knight has launched MINJUVI® in Brazil, Mexico and Argentina for use 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 DLCBL arising from low grade lymphoma in Brazil, who are not eligible for autologous stem cell transplantation (ASCT).