Eisai Co., Ltd., a Japanese pharmaceutical company headquartered in Tokyo, Japan, announced that the U.S. FDA granted its lenvatinib Breakthrough Therapy Designation (BTD) for the investigational use in patients with advanced or metastatic renal cell carcinoma (RCC) who were previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy. RCC accounts for over 90% of all kidney cancers and is frequently asymptomatic discovered often incidentally during imaging for unrelated illness. Consequently, an estimated one third of RCC was metastasized at presentation. In addition, RCC is relatively chemo- and radiation-insensitive representing a strong clinical need for the development of effective treatment options. Lenvatinib (Lenvima®) is a multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits several proangiogenic and oncogenic pathway-related RTKs. It is approved in the United States, Japan and Europe for the treatment of refractory thyroid cancer and is currently under investigation for treatment of other solid tumors such as hepatocellular carcinoma, endometrial carcinoma and non-small cell lung cancer. This BTD is based on the promising results of a Phase II trial involving lenvatinib in advanced or metastatic RCC.