The FDA has approved Eisai's lenvatinib (Lenvima) for the treatment of advanced renal cell carcinoma in combination with everolimus after prior antiangiogenic therapy.
The FDA has approved Eisai’s lenvatinib (Lenvima) for the treatment of advanced renal cell carcinoma in combination with everolimus after prior antiangiogenic therapy.
The FDA based its decision on results from a study in which the once-daily combination of 18 mg Lenvima and 5 mg everolimus led to a substantial improvement in progression-free survival. The treatment also showed strong objective response rate and clinically meaningful overall survival when compared with everolimus alone.
"This combination regimen led to enhanced efficacy and helped patients with advanced renal cell carcinoma live longer without disease progression or death than those treated with everolimus alone,” principal investigator Robert Motzer, MD, from the Memorial Sloan Kettering Cancer Center, said in a press release. These noteworthy findings advance the treatment paradigm for this patient population."
Some of the serious adverse effects associated with the combination of Lenvima and everolimus include hypertension, cardiac dysfunction, and arterial thromboembolic events.
Some of the most common adverse effects were diarrhea, fatigue, decreased appetite, arthralgia, vomiting, and nausea.
Renal cell carcinoma rates have been on the rise over the last few decades.
Lenvima was first approved by the FDA in February 2015 for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.