Incyte brazilian affiliate submits authorization for pemigatinib to ANVISA

Knight Therapeutics announced that its Brazilian affiliate, United Medical, 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, or 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. 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. Knight has also submitted marketing authorization applications for tafasitamab in Colombia, Mexico and Argentina.