Micrograph of a clear cell renal cell carcinoma. Credit: Nephron.

The National Institute for Health and Care Excellence (NICE) has recommended the use of Eisai’s Kisplyx (lenvatinib) combined with everolimus to treat advanced renal cell carcinoma (RCC).

The recommendation involves indication for adults who have undergone one previous vascular endothelial growth factor (VEGF)-targeted therapy.

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Lenvatinib is being developed as an oral multikinase inhibitor for vascular endothelial growth factor receptor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor-alpha, and RET and KIT proto-oncogenes.

Everolimus is designed to selectively inhibit mechanistic target of rapamycin (mTOR), which is a key serine-threonine kinase.

Eisai Oncology business group EMEA chairman and CEO Gary Hendler said: “We are delighted that NICE is recommending lenvatinib in combination with everolimus for routine access to adult patients for the treatment of advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.

“RCC is difficult to treat and patients therefore need effective alternative treatment options when their disease progresses.”

“RCC is difficult to treat and patients therefore need effective alternative treatment options when their disease progresses.”

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NICE’s decision is based on results obtained from the randomised study 205 conducted in 153 subjects with advanced RCC that had progressed following one prior VEGF therapy.

According to the data, significant differences were observed in efficacy with lenvatinib and everolimus combination, when compared to everolimus monotherapy.

The firm expects to obtain a further NICE recommendation for lenvatinib early next year for treating progressive, locally advanced or metastatic, differentiated thyroid carcinoma (DTC), refractory to radioactive iodine (RAI) in adults who have already waited around three years.