An Immunotherapy Option for Treating Kidney Cancer 

The FDA has approved an immunotherapy known as immune checkpoint inhibition for the treatment of certain patients with kidney cancer. 

The U.S. Food and Drug Administration (FDA) has approved the immunotherapeutic pembrolizumab (Keytruda) for certain patients with high-risk renal cell carcinoma, a type of kidney cancer, who are at risk of disease recurrence following surgery. 

Pembrolizumab is  an immune checkpoint inhibitor—a type of immunotherapy that releases the natural brakes on the immune system so that it can more easily fight tumors. Pembrolizumab is an antibody that blocks the inhibitory protein PD-1 on the surface of immune cells called T cells, thereby enhancing the cancer-killing activity of the T cells. 

The approval is based on data from a multicenter, randomized, double-blind, placebo-controlled clinical trial in which 994 patients with renal cell carcinoma were treated with pembrolizumab or a placebo. Patients receiving pembrolizumab were 32 percent less likely to experience a disease recurrence. 

Renal cell carcinoma arises in small tubules within the kidney. The National Cancer Institute predicted that more than 76,000 cases would be diagnosed in the United States in the year 2021, resulting in more than 13,000 deaths. 

The FDA rendered its approval on November 17, 2021.