FDA Approves Lenvatinib in Combination with Everolimus for RCC Treatment


Lenvatinib with everolimus previously granted Breakthrough Therapy Designation and Priority Review.

The FDA recently approved lenvatinib in combination with everolimus as treatment for advanced renal cell carcinoma (RCC) after 1 previous anti-angiogenic therapy.

Lenvatinib was approved in 2015 for treating radioactive iodine-refractory differentiated thyroid cancer.

The approval was based on results from a study that included 153 patients with advanced or metastatic RCC previously administered anti-angiogenic therapy. Patients either received lenvatinib in combination with everolimus, lenvatinib monotherapy, or everolimus monotherapy once daily. Metastases were present in 95% of patients.

Researchers found that patients treated with lenvatinib in combination with everolimus showed superior progression free survival, objective response rate, and overall survival compared with patients receiving lenvatinib monotherapy.

The most common adverse reactions associated with lenvatinib plus everolimus were diarrhea, fatigue, arthralgia/myalgia, decreased appetite, vomiting, nausea, stomatitis/oral inflammation, hypertension, peripheral edema, cough, abdominal pain, dyspnea, rash, decreased weight, bleeding events, and proteinuria, according to the study.

Lenvatinib in combination with everolimus was also granted Breakthrough Therapy Designation for RCC following 1 anti-angiogenic therapy and was also granted Priority Review.

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