A New Treatment Option for Advanced Kidney Cancer

The newly approved therapeutic improved survival for patients with the most common type of kidney cancer compared with standard treatment

The U.S. Food and Drug Administration (FDA) recently approved cabozantinib (Cabometyx) for treating certain patients with the most common form of kidney cancer diagnosed in U.S. adults—renal cell carcinoma.

Cabozantinib is intended for patients with advanced renal cell carcinoma that has progressed despite treatment with at least one antiangiogenic therapeutic, a type of anticancer agent that prevents tumors from establishing the blood and lymphatic vessel networks they need to grow and survive. Cabozantinib improved overall survival for patients compared with a standard treatment in a randomized phase III clinical trial.

Cabozantinib is itself an antiangiogenic therapeutic. In fact, there are currently 11 antiangiogenic therapeutics approved by the FDA. Each targets a combination of the many molecules that promote the growth of new blood and lymphatic vessel networks within a tumor.

Several of the antiangiogenic therapeutics are standard treatments for advanced renal cell carcinoma. However, resistance to these agents frequently arises within a year, and disease progresses. At this point, patients are often treated with a second antiangiogenic therapeutic, because each of these agents targets slightly different combinations of the molecules that enable tumors to survive and grow.

The approval of cabozantinib for advanced renal cell carcinoma was based on results from the randomized, phase III METEOR clinical trial. Initial results from the trial, published in The New England Journal of Medicine in November 2015, showed that cabozantinib increased the time before disease progressed for patients with renal cell carcinoma who had previously been treated with one or more antiangiogenic therapeutics compared with everolimus (Afinitor), which is a recommended treatment in this situation. The FDA stated that median overall survival was also improved among those assigned cabozantinib compared with those assigned everolimus. Specifically, median overall survival was 21.4 months for the cabozantinib arm compared with 16.5 months for the everolimus arm.

Cabozantinib is the second therapeutic to be recently approved for treating patients with renal cell carcinoma whose disease has progressed despite treatment with at least one antiangiogenic therapeutic. The immunotherapeutic nivolumab (Opdivo) was approved for the same patient population in November 2015. With the five-year relative survival rate for advanced kidney and renal pelvis cancer standing at just 11.7 percent, it is clear that new treatment options like these are urgently needed for patients with these cancers, and we hope to see more in the near future.

The FDA approval was rendered on April 11, 2016.