Lenvima is an orally administered molecular targeted agent which inhibits the activities of several different molecules including VEGFR, FGFR, RET, KIT and PDGFR.
It particularly inhibits VEGFR, FGFR and RET, which are especially involved in tumor angiogenesis and proliferation of thyroid cancer.
The approval was based on data from a multicenter, randomized, double-blind, placebo-controlled Phase III trial (the Select study) on progressive RAI refractory DTC.
In the trial’s primary endpoint of progression-free survival (PFS), Lenvima showed a statistically significant extension in PFS compared to placebo.
The drug also showed a statistically significant improvement in objective response rate compared to placebo, while a complete response was observed in 1.5% of the Lenvima group and none in the placebo group.
In the trial, the most common treatment-related adverse events observed were hypertension, diarrhea, fatigue or asthenia, decreased appetite, weight loss and nausea.
Discovered at Eisai’s Tsukuba Research Laboratories and developed in-house, Lenvima was launched in the US this February.
The drug was approved in Japan in March to treat unresectable thyroid cancer.
Image: Eisai head office in Tokyo, Japan. Photo: courtesy of Arthena.