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FDA approves Opdivo for advanced renal cell carcinoma
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The FDA today approved nivolumab to treat patients with advanced renal cell carcinoma who had received prior antiangiogenic therapy, according to a press release.
Nivolumab (Opdivo, Bristol-Myers Squibb) may help the body’s immune system to fight cancer cells by blocking the PD-1/PD-L1 pathway.
Richard Pazdur
“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.”
The FDA based its approval in part on safety and efficacy data from an open-label, randomized study comparing nivolumab with everolimus (Afinitor, Novartis) among 821 patients with advanced renal cell carcinoma (RCC) whose disease worsened during or after treatment with an antiangiogenic agent.
Overall, patients assigned nivolumab achieved a median OS of 25 months, compared with a median OS of 19.6 months among patients treated with everolimus. This benefit persisted regardless of PD-L1 expression.
Further, 21.5% of patients assigned nivolumab experienced complete or partial shrinkage of tumors, which lasted an average of 23 months. In the everolimus arm, 3.9% of patients experienced any shrinkage of tumors, lasting an average of 13.7 months.
The most common side effects associated with nivolumab included abnormal weakness, cough, nausea, rash, dyspnea, diarrhea, constipation, decreased appetite, back pain and arthralgia.
Nivolumab may also cause severe immune-mediated side effects to healthy organs that include the lung, colon, liver and the brain.
The FDA previously granted breakthrough therapy designation to nivolumab for advanced RCC.