FDA approves new indication for Opdivo

SILVER SPRING, Md. — The Food and Drug Administration on Monday announced that it had approved Opdivo (nivolumab) for patients with metastatic renal cell carcinoma (a type kidney cancer) who have received certain earlier treatment.

“Opdivo provides an important therapy option for patients with renal cell carcinoma,” said Dr. Richard Pazdur, 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.”

The National Cancer Institute estimates 61,560 new cases of renal cell carcinoma in the United States this year, as well as 14,080 deaths. Opdivo works by blocking the PD-1/PD-L1 cellular pathway , which may help the immune system fight cancer cells. This is the third indication for Opdivo, which has also been approved as a treatment for some cases of melanoma and non-small cell lung cancer.