The U.S. Food and Drug Administration has approved nivolumab (Opdivo) for the treatment of patients with metastatic renal cell carcinoma (mRCC) who have received prior anti-angiogenic therapy.1

“Opdivo provides an important therapy option for patients with renal cell carcinoma,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is one of few therapies that have demonstrated the ability to extend patients’ survival in treating this disease.”

Approval was based on an open-label study that compared nivolumab with everolimus in 821 patients with advanced RCC who experienced disease progression during or after treatment with an anti-angiogenic agent.

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The overall response rate was 21.5% in the nivolumab group vs 3.9% in the everolimus group. Median overall survival was 25.0 months (95% CI, 21.8 – not estimable) and 19.6 months (95% CI, 17.6 – 23.1), respectively (HR, 0.73; 95% CI, 0.57 – 0.93; P = .002).

In regard to safety, grade 3 or 4 treatment-related adverse events occurred in 19% of those who received nivolumab and in 37% of those who received everolimus. The most common side effects with nivolumab were asthenia, cough, nausea, rash, dyspnea, diarrhea, constipation, decreased appetite, and arthralgia.

Health care providers should be aware that nivolumab may cause serious immune-mediated side effects that involve health organs, such as the lung, colon, liver, kidneys, thyroid, and brain.

Nivolumab is to be administered at a dose of 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity.

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Nivolumab is already approved for the treatment of patients with unresectable or metastatic melanoma and patients with metastatic non-small cell lung cancer.

“Opdivo’s extended indication, from melanoma and non-small cell lung cancer to renal cell cancer, demonstrates how immune therapies can benefit patients across a wide range of tumors,” Dr. Pazdur noted.


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