EMA CHMP receives positive opinion for Eisai’s combination treatment for RCC

24 July 2016 (Last Updated July 24th, 2016 18:30)

Japanese-based Eisai has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on lenvatinib mesylate in combination with everolimus, to treat adult patients with advanced renal cell carcinoma (RCC).

Japanese-based Eisai has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on lenvatinib mesylate in combination with everolimus, to treat adult patients with advanced renal cell carcinoma (RCC).

To be launched under the brand name Kisplyx, the anti-cancer agent lenvatinib mesylate can treat adult RCC patients after one prior vascular endothelial growth factor (VEGF) targeted therapy.

Lenvatinib is an orally administered, multiple receptor tyrosine kinase (RTK) inhibitor with an effective binding mode that particularly inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors and fibroblast growth factor (FGF) receptors.

"Advanced or metastatic RCC is currently difficult to treat with surgery, while the basic treatment method is molecular targeted drug therapy with five years of low survival rates."

The drug inhibits the additional proangiogenic and oncogenic pathway-related RTKs that includes the platelet-derived growth factor (PDGF) receptor PDGFRalpha, KIT, and RET, involved in tumour proliferation.

Advanced or metastatic RCC is currently difficult to treat with surgery, while the basic treatment method is molecular targeted drug therapy with five years of low survival rates.

At present, Lenvatinib, under the product name Lenvima, has been introduced in several countries across the world that includes the US, Japan and different nations in Europe for treating patients with refractory thyroid cancer.

In May this year, lenvatinib, in combination with everolimus, was approved by the US Food and Drug Administration (FAA) to treat patients with advanced RCC after one prior VEGF-targeted therapy.