The Food and Drug Administration has approved lenvatinib capsules, in combination with everolimus, for the treatment of patients with advanced renal cell carcinoma following one prior antiangiogenic therapy.
Approval was based on prolonged progression-free survival (PFS) in a randomized, phase II, open-label multicenter clinical trial of 153 patients, the FDA said in a written statement .
Patients who received lenvatinib plus everolimus (n = 51) had significantly prolonged PFS, compared with patients who received only everolimus (n = 50) (14.6 months vs. 5.5 months; HR, 0.40; 95% CI, 0.24-0.68; P = .0005) but not compared with patients who received lenvatinib alone (n = 52) (7.4 months; HR, 0.66; 95% CI, 0.30-1.10; P = .12). Of patients receiving the combination of drugs, 71% experienced adverse events, compared with 79% of patients receiving lenvatinib alone and 50% of patients receiving everolimus alone. The most common treatment-related adverse events reported included diarrhea, decreased appetite, and severe fatigue.
The FDA previously granted lenvatinib, marketed as Lenvima by Eisai, a breakthrough therapy designation and priority review.
“This is the only combination regimen to significantly prolong progression-free survival … when compared with a standard of care in patients with advanced renal cell carcinoma,” representatives from Eisai said in a written statement .
Lenvatinib was previously approved for the treatment of recurrent, progressive, radioactive iodine-refractory differentiated thyroid cancer in early 2015. However, in April 2016, the FDA released a safety warning about lenvatinib capsules for oral use.
“Serious tumor-related bleeds, including fatal hemorrhagic events in Lenvima-treated patients, have occurred in clinical trials and been reported in postmarketing experience,” reported the FDA in a written statement .
The recommended lenvatinib dosage for renal cell carcinoma patients is 18 mg/day, lower than the 24 mg/day that was recommended to thyroid cancer patients prior to the FDA’s warning.
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