Nivolumab (Opdivo) has received FDA approval for treating patients with metastatic renal cell carcinoma (RCC) whose disease advanced despite prior treatment with an anti-angiogenic agent.

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


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Temsirolimus, which was approved in 2007, is the only other FDA-approved treatment shown to improve overall survival in patients with metastatic RCC, according to the agency.


The safety and efficacy of nivolumab were demonstrated in an open-label, randomized study of 821 patients with advanced RCC whose disease worsened during or after treatment with an anti-angiogenic agent. Patients were treated with nivolumab or everolimus (marketed as Afinitor).


The nivolumab arm had significantly longer survival than the everolimus arm (average 25 vs. 19.6 months). In addition, 21.5% of nivolumab recipients experienced complete or partial shrinkage of their tumors compared with 3.9% of subjects receiving everolimus.


Nivolumab is marketed by Bristol-Myers Squibb of Princeton, N.J.