On June 10, 2015 Eisai reported that its U.K. subsidiary Eisai Europe Ltd. has launched its in-house developed novel anticancer agent Lenvima (lenvatinib mesylate) indicated for the treatment of adult patients with progressive, locally advanced or metastaticdifferentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC) refractory to radioactive iodine (RAI) in the United Kingdom (Press release, Eisai, JUN 10, 2015, View Source [SID:1234505384]). Following the launch of Lenvima in the United Kingdom, Eisai plans to launch the agent in countries throughout Europe. Schedule your 30 min Free 1stOncology Demo! It is estimated that thyroid cancer affects more than 52,000 people in Europe each year. Differentiated thyroid cancer is the most common form of thyroid cancer and accounts for approximately 95% of all thyroid cancers. Although most differentiated thyroid cancers can be treated with surgery and radioactive iodine treatment, there are few treatment options available once the cancer has progressed, therefore it remains a disease with significant unmet medical needs.
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In a global Phase III study (the SELECT study) of Lenvima in differentiated thyroid cancer, Lenvima demonstrated a statistically significant extension in progression free survival and improved response rates compared to placebo 1. The most common Lenvima treatment-related adverse events were hypertension, diarrhea, fatigue or asthenia, decreased appetite, weight loss and nausea. Lenvima was granted an accelerated assessment by the European Medicines Agency, and was approved on May 28, 2015.
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. In particular, the agent simultaneously inhibits VEGFR,FGFR and also RET, which are especially involved in tumor angiogenesis and proliferation of thyroid cancer. Furthermore, Lenvima has been confirmed through X-ray co-crystal structural analysis to demonstrate a new binding mode (Type V) to VEGFR2, and exhibits rapid binding to the target molecule and potent inhibition of kinase activity, according to kinetic analysis2.
Lenvima was first launched in the United States indicated for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer in February 2015, and was subsequently launched in Japan for the treatment of unresectable thyroid cancer in May 2015. Eisai is aiming to launch the agent in over 20 countries in fiscal 2015. 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.
In addition to providing Lenvima as a new treatment option for thyroid cancer, Eisai is committed to exploring the potential clinical benefits of Lenvima in order to further contribute to, and address the diverse needs of, patients with cancer and their families.