Nivolumab Indications Extended to Include Advanced Renal Cell Carcinoma

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The FDA extended indications for nivolumab (Opdivo) to include treatment of advanced (metastatic) renal cell carcinoma.
The FDA extended indications for nivolumab (Opdivo) to include treatment of advanced (metastatic) renal cell carcinoma.

The US Food and Drug Administration (FDA) extended indications for nivolumab (Opdivo) to include treatment of advanced (metastatic) renal cell carcinoma (RCC) in patients with the disease who have received prior antiangiogenic therapy.1

“[Nivolumab] is one of few therapies that have demonstrated the ability to extend patients' survival in treating this disease,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research.

Nivolumab works by blocking the PD-1/PD-L1 cellular pathway, which may help the body's immune system fight cancer cells. It is intended for patients with RCC who have undergone previous antiangiogenic therapy.

Approval for this use is based on an open-label, randomized study of 821 patients with advanced RCC whose disease worsened during or after undergoing treatment with an antiangiogenic agent. Patients were randomized to receive nivolumab or everolimus (Afinitor).

Results showed that those receiving nivolumab lived an average of 25 months after starting treatment vs. 19.6 months for those who received everolimus; an effect that was observed regardless of tumors' PD-L1 expression level.

In addition, complete or partial tumor shrinkage was seen in 21.5% of patients treated with nivolumab, with the effect lasting an average of 23 months. In comparison, complete or partial shrinkage of tumors was seen in 3.9% of those treated with everolimus, with the effect lasting an average of 13.7 months.

The most common side effects reported by patients with advanced RCC taking nivolumab were abnormal weakness or lack of energy, cough, nausea, rash, difficulty breathing, diarrhea, constipation, decreased appetite, back pain, and joint pain.

Potential serious side effects of nivolumab include immune-mediated effects involving healthy organs, including the lung, colon, liver, kidneys, hormone-producing glands, and the brain.


1. FDA approves Opdivo to treat advanced form of kidney cancer [news release]. Silver Spring, MD: US Food and Drug Administration; November 23, 2015. Accessed November 25, 2015.

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