Eisai Europe has obtained approval from the European Commission (EC) for its anticancer agent Lenvima (lenvatinib mesylate) to treat adult patients with progressive, locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
Lenvima is an orally administered molecular targeted agent, which selectively prevents the activities of several different molecules, including VEGFR, FGFR, RET, KIT and PDGFR.
Discovered at Eisai’s Tsukuba Research Laboratories and developed in-house, the drug simultaneously inhibits VEGFR, FGFR, and RET that are especially involved in tumour angiogenesis and proliferation of thyroid cancer.
Approval follows a muticentre, randomised, double-blind and placebo-controlled Phase III trial (select study) on progressive RAI refractory DTC.
During the study to compare primary endpoint of progression-free survival (PFS) of patients, Lenvima claimed to have showed a statistically significant extension in PFS compared to placebo.
In addition, the drug showed a statistically significant improvement in objective response rate compared to placebo and complete response was observed in 1.5% of the Lenvima group and none in the placebo group, the company said.
In February, Lenvima was launched in the US to treat locally recurrent or metastatic, progressive and radioactive iodine-refractory differentiated thyroid cancer.
In March this year, Lenvima received approval in Japan to treat unresectable thyroid cancer and is currently undergoing regulatory review in seven other countries.
At present, the company is carrying out clinical studies of Lenvima in several types of cancer, including hepatocellular carcinoma (Phase III), renal cell carcinoma (Phase II), non-small cell lung cancer (Phase II) and endometrial cancer (Phase II).
