The novel anticancer agent lenvatinib mesylate – in-house developed by Eisai and indicated for the treatment of adult patients with progressive, locally advanced or metastatic differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC) refractory to radioactive iodine (RAI) – is now available on the market in the United Kingdom.
In a global Phase III study (the SELECT study) in differentiated thyroid cancer, the product demonstrated a statistically significant extension in progression free survival and improved response rates compared to placebo.
The new drug also received a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the potential indication of advanced and/or metastatic renal cell carcinoma. The Breakthrough Therapy designation is a program intended to expedite development and review of drugs for serious or life-threatening conditions: benefits include more intensive guidance on an efficient drug development program and submission strategy, as well as eligibility for rolling review. The Breakthrough Therapy designation was based on the results of a Phase II clinical trial (Study 205) of lenvatinib in advanced or metastatic renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy.