Urology FDA approvals of 2016
FDA approves combination regimen to treat advanced RCC
Eisai Inc. has announced that it has received FDA approval for lenvatinib (Lenvima), a multiple receptor tyrosine kinase inhibitor, in combination with everolimus (Afinitor) for the treatment of individuals with advanced renal cell carcinoma who were previously treated with an anti-angiogenic therapy. During the registration study, the once-daily combination of lenvatinib, 18 mg, and everolimus, 5 mg, demonstrated an improvement in progression-free survival, objective response rate, and overall survival when compared with treatments using only everolimus. Patients using the combination therapy experienced a 63% reduction in the risk of disease progression or death compared with everolimus alone. The combination regimen also saw patients experience a 10.1-month increase in average overall survival versus everolimus monotherapy. The most common adverse reactions in study patients were hypertension, cardiac dysfunction, arterial thromboembolic events, hepatotoxicity, proteinuria, diarrhea, renal failure and impairment, gastrointestinal perforation and fistula formation, and QT interval prolongation.
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