On January 4, 2022 Knight Therapeutics Inc. (TSX:GUD) ("Knight" or "the Company") reported that its Colombian affiliate, Biotoscana Farma S.A. has obtained INVIMA approval for Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor developed by Eisai, for the treatment of radioiodine refractory differentiated thyroid cancer (RR-DTC) and unresectable hepatocellular carcinoma (u-HCC) (Press release, Knight Therapeutics, JAN 4, 2022, View Source [SID1234598111]).
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Lenvima (lenvatinib) demonstrated a statistically significant progression-free survival prolongation and response rate in patients with progressive, differentiated thyroid cancer who had become refractory to radioactive iodine therapy1. In a separate study in patients with previously untreated unresectable HCC2, Lenvima (lenvatinib) was proven to be non inferior to sorafenib for overall survival. In addition, Lenvima (lenvatinib) was statistically significantly superior to sorafenib for progression-free survival and objective response rate. In 2020, there were approximately 5,3043 new patients with thyroid cancer and 2,2893 new patients with liver cancer in Colombia.
"We’re pleased to announce the approval of Lenvima (lenvatinib) in Colombia as it provides a new treatment option for radioiodine refractory differentiated thyroid cancer and unresectable hepatocellular carcinoma," said Samira Sakhia, President & Chief Executive Officer. "We look forward to working with payors to ensure access to the product for all patients who can benefit from Lenvima (lenvatinib)."
Knight has an exclusive license from Eisai to commercialize Lenvima (lenvatinib), Halaven (eribulin mesylate), Fycompa (perampanel) and Inovelon (rufinamide) throughout Latin America, with the exception of Mexico where Eisai retains the rights to Halaven (eribulin mesylate) and Lenvima (lenvatinib).
About LENVIMA (lenvatinib); available as 10mg and 4mg capsules
LENVIMA (lenvatinib), discovered and developed by Eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA (lenvatinib) inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET.
Currently, LENVIMA (lenvatinib) has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including Japan, in Europe, China and in Asia, and in the United States for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. In addition, LENVIMA (lenvatinib) has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including Japan, in Europe, China and in Asia, and in the United States for first-line unresectable hepatocellular carcinoma. LENVIMA (lenvatinib) has been approved for monotherapy as a treatment for unresectable thymic carcinoma in Japan. It has also been approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in Europe and Asia, and in the United States the treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma. LENVIMA (lenvatinib) has been approved in combination with KEYTRUDA (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) in the United States. LENVIMA (lenvatinib) has been approved in combination with KEYTRUDA (generic name: pembrolizumab) as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the United States, and has been approved for the similar indication (including conditional approval) in over 10 countries such as Canada and Australia. In some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials.