Opdivo (nivolumab) has been approved to treat advanced renal cell carcinoma, the most common type of kidney cancer.
The drug targets proteins that would otherwise hinder the body's immune system in fighting cancer cells, the agency said in a news release.
Renal cell carcinoma is expected to be diagnosed in more than 61,000 Americans this year, and more than 14,000 are projected to die from it, the FDA said, citing the National Cancer Institute.
Opdivo was previously approved to treat melanoma skin cancer and non-small cell lung cancer.
The drug's newest approval is meant for people who have had prior anti-angiogenic therapy, which is a treatment that interferes with the blood vessels that contribute to the growth of cancer cells.
Opdivo was evaluated for this purpose in a study of more than 820 people whose disease progressed despite anti-angiogenic therapy. People who took Opdivo lived an average of 25 months, compared to about 19 months among people treated with another drug, Afinitor, the agency said.
The most common side effects of Opdivo included lack of energy, cough, nausea, rash and difficulty breathing. 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.
Opvido is marketed by Princeton, N.J.-based Bristol-Myers Squibb.