FDA Expands Lenvima Use in Renal Cell Carcinoma

The new approval is based on Phase 2 trial that included 153 patients
The new approval is based on Phase 2 trial that included 153 patients

Eisai announced that the Food and Drug Administration (FDA) has approved Lenvima (lenvatinib) in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (aRCC) who were previously treated with an antiangiogenic therapy.

The FDA approval of Lenvima was based on data from the Phase 2 trial (Study 205; n=153) where Lenvima 18mg plus everolimus 5mg once daily showed a substantial improvement in progression-free survival (PFS), powerful objective response rate (ORR), and clinically meaningful overall survival (OS) vs. everolimus alone. The median PFS in the combination treatment group was 14.6 months (95% CI: 5.9–20.1) vs. 5.5 months (95% CI: 3.5–7.1) in the everolimus only group (hazard ratio [HR] 0.37, 95% CI: 0.22–0.62). In addition, the combination regimen led to a 63% reduction in the risk of disease progression or death vs. everolimus alone. 

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This combination marks the first FDA-approved regimen that utilizes tyrosine kinase and mTOR inhibition. Lenvima plus everolimus demonstrated increased antiangiogenic and antitumor activity as shown by decreased human endothelial cell proliferation, tube formation, and VEGF signaling. 

Lenvima, a multiple receptor tyrosine kinase inhibitor, was initially approved for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). It was later granted Breakthrough Therapy designation by the FDA and received Priority Review. 

Lenvima is available as 4mg and 10mg capsules in cartons of 6 cards. Each card is a 5-day blister card. 

For more information call (888) 422-4743 or visit Lenvima.com

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