Nivolumab Now FDA Approved for Advanced RCC

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FDA Approves Opdivo for Advanced Renal Cell Carcinoma
FDA Approves Opdivo for Advanced Renal Cell Carcinoma

Opdivo (nivolumab) has been approved by the U.S. Food and Drug Administration to treat advanced renal cell carcinoma.

Opdivo, which targets the PD-1/PD-L1 cellular pathway, was previously approved to treat melanoma and non-small-cell lung cancer. The drug's newest approval is meant for patients who have had prior anti-angiogenic therapy.

Opdivo was evaluated in a study of 821 patients with advanced renal cell carcinoma whose disease progressed despite anti-angiogenic therapy. Patients who took Opdivo lived an average of 25 months, compared to about 19 months among patients treated with another drug, Afinitor (everolimus), the agency said. The most common side effects of Opdivo included lack of energy, cough, nausea, rash, and dyspnea. The drug's effects on the immune system also could cause serious problems with healthy organs, including the lung, colon, liver, kidney, and brain, the FDA said.

"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," Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

Opvido is marketed by Princeton, N.J.-based Bristol-Myers Squibb.

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