FDA Approves Lenvatinib Together with Everolimus for Stage 4 Kidney Cancer

The American Food and Drug Administration (FDA) approved use of the kinase inhibitor lenvatinib in stage 4 (metastatic) kidney cancer treatment. This new drug is intended for combined use with everolimus in kidney cancer patients previously receiving 1 line of antiangiogenic treatment.

Approval for the drug followed a study including 153 patients with advanced kidney cancer. Patients were divided into 3 groups;

1. one group received lenvatinib together with everolimus,
2. another group received lenvatinib alone,
3. and another received everolimus alone.

During the study, 95% of patients had various metastases.

According to the Study Results;

• In the group receiving lenvatinib with everolimus, progression-free survival (the time until disease worsening was detected) was 14,6 months, compared with 5,5 months in the group receiving everolimus alone.
• In the group receiving lenvatinib with everolimus, median overall survival was 25,5 months, compared with 15,4 months in those receiving everolimus alone.

Regarding treatment safety, the most frequently observed serious side effects were diarrhea, weakness, hypertension and kidney failure.

Both drugs are taken orally as pills, with recommended daily doses for lenvatinib of 18 mg and everolimus of 5 mg.

Dear readers, this new drug is currently approved for use only in America. If these favorable treatment results are supported by further studies, this treatment is likely to receive approval in our country in the coming periods.