Knight Therapeutics Announces Launch of Minjuvi in Brazil

MONTREAL, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of Minjuvi (tafasitamab) by its Brazilian affiliate, United Medical Ltda. Minjuvi is indicated 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).

DLBCL, the most common subtype of non-Hodgkin lymphoma, presents an aggressive clinical profile. Although a significant number of patients can be cured with standard front-line therapy, many will exhibit refractory disease or relapse following an initial response and are ineligible to transplant. These patients face a very poor prognosis and need novel treatment option to improve their outcomes¹.

According to NCCN Guidelines, Minjuvi is listed as one of the preferred 2^nd line treatments for DLBCL patients who are ineligible for transplantation². The marketing authorization was based on the data from L-MIND study, an open label, multicenter, single arm Phase 2 trial. The primary endpoint results showed an objective response rate (ORR) of 60%, which includes a complete response rate (CR) of 43% and a disease control rate (DCR) of 75%³.

“The launch of Minjuvi brings a new treatment option to relapsed or refractory non-transplant eligible DLBCL adult patients due to its innovative characteristics and proven efficacy, with a reasonable safety profile,” said Dr Guilherme Perini, hematologist specialized in Lymphomas at Hospital Israelita Albert Einstein. “Minjuvi will improve patients’ standard of care and it is a highly anticipated therapy for our patients,” added Dr Perini.

In September 2021, Knight entered into a supply and distribution agreement with Incyte (NASDAQ: INCY), for the exclusive rights to distribute pemigatinib (Pemazyre) as well as tafasitamab (sold as Monjuvi in the United States and Minjuvi in Europe) in Latin America. In July 2023, ANVISA (Agência Nacional de Vigilância Sanitária) granted Market Authorization for Minjuvi under the rare disease designation according to Resolution RDC 205/2017. Additionally, in October 2023, Knight received pricing approval for Minjuvi from the Drugs Market Regulation Chamber (“CMED”).