South Korean approval for Eisai's cancer drug Lenvima

Japanese pharma major Eisai (TYO: 4523) says it has received marketing approval of its novel in-house developed anticancer agent Lenvima (lenvatinib mesylate) from the regulatory authority in South Korea (Ministry of Food and Drug Safety).

Lenvima is approved as a treatment for patients with progressive, locally recurrent or metastatic, differentiated thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). The marketing authorization application for Lenvima in South Korea was submitted in November 2014, and through the approval of this application, South Korea is the first country in Asia where Lenvima has been approved following Japan, the USA and Europe.

The decision to approve Lenvima in South Korea was based on the results of a pivotal Phase III study (the SELECT study) on DTC. In the study, Lenvima demonstrated a statistically significant extension in progression-free survival compared to placebo, as well as a high objective response rate. The most common Lenvima treatment-related adverse events were hypertension, diarrhea, fatigue or asthenia, decreased appetite, weight loss and nausea.

Already launched in Japan, USA and Europe

Lenvima has already been launched in Japan, the USA and Europe, while in Asia, applications seeking marketing approval are undergoing regulatory review in Singapore, Macao, Hong Kong, Taiwan, Malaysia, India and Indonesia. Furthermore, Eisai is conducting a global Phase III study of Lenvima in hepatocellular carcinoma as well as Phase II studies of Lenvima in several other tumor types such as renal cell carcinoma and non-small cell lung cancer.

Discovered at Eisai's Tsukuba Research Laboratories and developed in-house, Lenvima is an orally administered molecular targeted agent that selectively inhibits the activities of several different molecules including VEGFR, FGFR, RET, KIT and PDGFR.

The number of patients newly diagnosed with thyroid cancer in 2012 in South Korea was estimated to be 33,000, and in Asia was estimated to be 144,000. Although treatment is possible for most types of thyroid cancer, there are few treatment options available once thyroid cancer has progressed, therefore it remains a disease with significant unmet medical needs.