In April 2018, the FDA approved the use of 2 immunotherapies—Opdivo and Yervoy (nivolumab and ipilimumab; from Bristol-Myers Squibb)—for the treatment of patients with intermediate-risk or poor-risk advanced renal-cell carcinoma, or kidney cancer. This is the first immunotherapy regimen approved by the FDA for patients with kidney cancer. The majority of patients (about 75%) with advanced kidney cancer have disease that is considered at risk.
The FDA has previously approved this immunotherapy combination for use in patients with advanced melanoma and for patients with colorectal cancer. This new approval for kidney cancer was based on results from the clinical trial called CheckMate-214 that included 847 patients with intermediate-risk or poor-risk advanced kidney cancer who had not received any therapy before.
The use of the 2 immunotherapies led to improved outcomes in about 42% of patients compared with only about 27% of patients who received the targeted drug Sutent (sunitinib), which was previously approved for advanced kidney cancer.
The main side effects reported with nivolumab and ipilimumab in this study were fatigue, rash, diarrhea, musculoskeletal pain, nausea, cough, fever, joint inflammation, and decreased appetite.
