FDA approves Lenvima for advanced renal cell carcinoma

The FDA expanded the approval of lenvatinib to include use in combination with everolimus to treat patients with advanced renal cell carcinoma who underwent one prior antiangiogenic therapy.

The agency based the approval, in part, on results of a multicenter study that included 153 patients with advanced or metastatic renal cell carcinoma. All patients underwent prior antiangiogenic therapy.

Researchers randomly assigned patients to one of three daily treatment regimens: 18 mg lenvatinib (Lenvima, Eisai) plus 5 mg everolimus (Afinitor, Novartis); 24 mg lenvatinib; or 10 mg everolimus.

Investigators reported longer median PFS (14.6 months vs. 5.5 months), longer median OS (25.5 months vs. 15.4 months) and a higher objective response rate (37% vs. 6%) among patients assigned the combination than among patients assigned everolimus monotherapy, a standard of care for this patient population.

“Lenvatinib plus everolimus is the first and only FDA-approved regimen that successfully combines treatments that employ tyrosine kinase and mTOR inhibition, the primary targets of advanced renal cell carcinoma treatment for the past decade,” principal investigator Robert Motzer, MD, medical oncologist at Memorial Sloan Kettering Cancer Center, said in an Eisai-issued press release. “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. These noteworthy findings advance the treatment paradigm for this patient population.”

The most common adverse reactions observed in patients treated with the combination included diarrhea, fatigue, arthralgia/myalgia, decreased appetite, vomiting, nausea, stomatitis/oral inflammation, hypertension, peripheral edema, cough, abdominal pain, dyspnea, rash, weight decrease, hemorrhagic events and proteinuria.

The most common serious adverse reactions included renal failure (11%), dehydration (10%), anemia (6%), thrombocytopenia (5%), diarrhea (5%), vomiting (5%) and dyspnea (5%).

Adverse reactions led to dose reductions or interruption in 89% of patients who received the combination therapy and 54% of patients who received everolimus alone.

The FDA previously granted priority review and breakthrough therapy designations to lenvatinib for treatment of advanced or metastatic renal cell carcinoma.

The agency approved lenvatinib last year for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.