Nivolumab receives US FDA approval for use in advanced renal cell carcinoma

The US Food and Drug Administration (FDA) yesterday announced their approval of the immunotherapy agent nivolumab (Opdivo®; Bristol-Myers Squibb, NJ, USA) for the treatment of patients with metastatic renal cell carcinoma.

Now approved, nivolumab could represent an important therapy option for individuals with advanced renal cell carcinoma, for which temsirolimus is the only other FDA-approved therapy that has demonstrated an ability to improve overall survival.

“…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,” commented Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Nivolumab, an anti-PD-1 antibody therapy, is intended in the setting of metastatic renal cell carcinoma for the treatment of individuals who have previously received antiangiogenic therapies.

The data upon which this approval is based were generated in an open-label randomized study involving 821 patients with advanced disease that had progressed on antiangiogenic therapy. Patients were randomized to therapy with either nivolumab of everolimus; those receiving nivolumab lived an average of 25 months after starting treatment, compared with 19.6 months for those in the everolimus arm. This survival advantage was found to be independent of the PD-L1 expression level of patients’ renal cell tumors.

Nivolumab was also demonstrated to promote a complete or partial shrinkage of tumors in 21.5% of patients, compared with 3.9% in the everolimus arm.

Frequent side effects of nivolumab in this setting included conditions relating to abnormal weakness or lack of energy (asthenic conditions), cough, nausea, rash, dyspnea, diarrhea, constipation, decreased appetite, back pain and arthralgia. Nivolumab can also cause serious immune-mediated side effects involving healthy organs, including the lungs, colon, liver, kidneys, hormone-producing glands and the brain.

Pazdur stated that nivolumab “…provides an important therapy option for patients with renal cell carcinoma.”

Source: FDA press release