Knight Therapeutics Receives Lenvima Approval in Colombia

Knight Therapeutics Inc. announced that its Colombian affiliate, Biotoscana Farma S.A., has received approval from INVIMA, Colombia's health regulatory agency, for Lenvima® (lenvatinib). The approval covers indications for radioiodine-refractory differentiated thyroid cancer (RR-DTC) and unresectable hepatocellular carcinoma (u-HCC).

Clinical studies have demonstrated that Lenvima® significantly prolongs progression-free survival and improves response rates in patients with differentiated thyroid cancer that has become refractory to radioactive iodine therapy. In a separate study for previously untreated unresectable HCC, Lenvima® was found to be non-inferior to sorafenib for overall survival and superior for progression-free survival and objective response rate.

In 2020, Colombia saw approximately 5,304 new cases of thyroid cancer and 2,289 new cases of liver cancer. Knight Therapeutics President and CEO Samira Sakhia stated the company is pleased to offer a new treatment option and anticipates working with payers to ensure patient access.

Knight Therapeutics holds an exclusive license to commercialize Lenvima® throughout Latin America, excluding Mexico. Lenvima® is approved for thyroid cancer and HCC in numerous other countries, including in Europe and the United States.