Press release
Knight Therapeutics Announces Regulatory Submission of Pemigatinib in Brazil
MONTREAL, Oct. 10, 2023 (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, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) (\"Knight\") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltd., has submitted a marketing authorization application for pemigatinib to ANVISA, the Brazilian health regulatory agency, under the rare diseases approval pathway, for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Marketing authorization applications for pemigatinib have also been submitted previously in Colombia, Mexico and Argentina. “This milestone demonstrates Knight’s commitment to providing innovative therapies for important unmet healthcare needs in Latin America,” said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc. Cholangiocarcinoma is the malignant neoplasm of the primary biliary tract, being the intrahepatic type localized in the biliary duct ramifications inside the liver. This kind of tumor is considered rare, and more than 50% of the patients are diagnosed in advanced disease stages. 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 granted regulatory approval in Brazil for Minjuvi® in combination with lenalidomide followed by tafasitamab monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL due to low-grade lymphoma, who are not eligible for autologous stem cell transplantation (ASCT). Upon obtaining the marketing authorization from ANVISA, Knight submitted an application for pricing approval to the Drugs Market Regulation Chamber (“CMED”) which establishes maximum prices allowed for drugs sold in Brazil. The commercial launch of Minjuvi® is dependent upon the outcome of the pricing approval process which could take up to two years. Knight has also submitted marketing authorization applications for tafasitamab in Colombia, Mexico and Argentina. About Pemigatinib (Pemazyre®) Pemiga...