FDA approves Eisai’s Lenvima for advanced renal cell carcinoma

SILVER SPRING, Md. — The Food and Drug Administration on Friday approved a new indication for Eisai’s Lenvima (lenvatinib). The multiple receptor tyrosine kinase inhibitor has been approved to treat advanced renal cell carcinoma (RCC) in combination with everolimus in patients previously treated with an anti-angiogenic therapy. 

 

The drug, which was given Breakthrough Therapy designation and Priority Review by the FDA, managed to improve progression-free survival and demonstrated clinically meaningful overall survival in trials compared to everolimus alone in clinical trials. It had previously been approved to treat locally recurrent or metastatic, progressive, radioactive iodine-refractory thyroid cancer. 

 

“Rates of renal cell carcinoma have been on the rise over the past several decades, and unfortunately, advanced RCC remains an incurable disease,” Dr. Sumanta Kumar Pal, co-director of City of Hope’s kidney cancer program in Duarte, Calif., said. “The combination regimen of lenvatinib and everolimus provides a new treatment for patients with advanced RCC whose disease continues to progress despite prior treatment with an anti-angiogenic therapy.”

 

This is the second time that an oncology treatment from Eisai has been granted Priority Review status in four months, according to Eisai chief clinical officer and chief medical officer Dr. Alton Kremer. “By bringing this breakthrough treatment to patients with advanced RCC, Eisai now offers an efficacious option in a second difficult-to-treat tumor type, just 15 months after its initial approval, and we look forward to continued exploration of Lenvima in additional malignancies,” he said.