Metastic kidney cancer treatment submitted to the EMA

Lenvatinib, discovered and developed by Eisai, has been submitted for review by the European Medicines Agency (EMA) for use in combination with everolimus to treat people with metastatic kidney cancer 

Eisai has submitted a new Marketing Authorisation Application to the EMA for the use of lenvatinib in combination with everolimus, to treat people with unresectable advanced or metastatic renal cell carcinoma (mRCC) who have received one prior vascular endothelial growth factor (VEGF)-targeted therapy.

Everolimus is a treatment recommended by the National Comprehensive Cancer Network guidelines as a second-line therapy for unresectable advanced or metastatic renal cell carcinoma.

Lenvatinib is an oral molecular tri-specific targeted therapy that Eisai said has a potent selectivity.

The company’s EMA application is based on a phase two trial of lenvatinib, which when used in combination with everolimus showed progression-free survival was significantly extended in people with mRCC versus everolimus alone.

People treated with the combination regimen experienced a median progression-free survival of 14.6 months compared with 5.5 months for those who received everolimus alone according to Eisai.

Hilary Glen, consultant medical oncologist, Beatson West of Scotland Cancer Centre, said: "The phase two data showed that, for people with metastatic kidney cancer, the addition of lenvatinib offered a statistically significant progression free survival benefit compared to everolimus alone.

“The news that Eisai has submitted this application is hugely positive, for both clinicians and patients alike. “

Gary Hendler, president and CEO Eisai EMEA and president, Eisai Oncology Global Business Unit, said: "This submission is very important for clinicians, patients and Eisai. We hope that patients in Europe will not have to wait long before accessing the treatment."