FDA Approves Nivolumab to Treat Advanced Kidney Cancer

The U.S. Food and Drug Administration today approved nivolumab (Opdivo) to treat patients with metastatic renal cell carcinoma who have received a prior antiangiogenic therapy. Nivolumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway–mediated inhibition of the immune response.

“[Nivolumab] 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.” Temsirolimus (Torisel), approved in 2007, is the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer.

“Additionally, [nivolumab]’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,” continued Dr. Pazdur.

Clinical Trial

The safety and efficacy of nivolumab for this use were demonstrated in an open-label, randomized study of 821 patients with advanced renal cell carcinoma whose disease worsened during or after treatment with an antiangiogenic agent. Patients were treated with nivolumab or everolimus (Afinitor). Those treated with nivolumab lived an average of 25 months after starting treatment compared to 19.6 months in those treated with everolimus. This effect was observed regardless of the PD-L1 expression level of patients’ renal cell tumors. Additionally, 21.5% of those treated with nivolumab experienced a complete or partial shrinkage of their tumors, which lasted an average of 23 months, compared to 3.9% of those taking everolimus, lasting an average of 13.7 months.

The most common side effects of nivolumab for this use are conditions relating to abnormal weakness or lack of energy, cough, nausea, rash, difficulty breathing, diarrhea, constipation, decreased appetite, back pain, and joint pain. Nivolumab also has the potential to cause serious immune-mediated side effects involving the lung, colon, liver, kidneys, hormone-producing glands, and brain.  

The FDA granted the nivolumab application a breakthrough therapy designation, fast track designation, and priority review status. These are distinct programs intended to facilitate and expedite the development and review of certain new drugs in light of their potential to benefit patients with serious or life-threatening conditions.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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