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FDA Approves Nivolumab for Metastatic Renal Cell Carcinoma

Dr. Richard Pazdur

Richard Pazdur, MD

The FDA has approved nivolumab (Opdivo) as a treatment for patients with metastatic renal cell carcinoma (RCC) following prior treatment with an anti-angiogenic therapy, based on an extension in overall survival (OS) in the CheckMate-025 trial.

In the pivotal phase III study, nivolumab reduced the risk of death by 27% versus everolimus (Afinitor), representing a 5.4-month improvement in median OS. Grade 3/4 adverse events (AEs) were also lower with the PD-1 inhibitor compared with everolimus. The approval for nivolumab follows a breakthrough therapy designation and was granted nearly 4 months ahead of schedule.

"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 statement. "It is one of few therapies that have demonstrated the ability to extend patients' survival in treating this disease." Click here to read the full article at

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