The Food and Drug Administration has approved nivolumab for the treatment of patients with metastatic renal cell carcinoma who have previously received antiangiogenic therapy, expanding on approval of the PD-1 inhibitor for melanoma and non–small cell lung cancer.
The approval was based on improvement in overall survival in CheckMate 025, an open-label, randomized study involving 821 patients with advanced renal cell carcinoma whose disease worsened during or after treatment with an antiangiogenic agent. Patients were treated with nivolumab or everolimus. Median overall survival was 25 months with nivolumab and 19.6 months with everolimus, representing a 27% reduction in the risk of all-cause death (hazard ratio for death, 0.73; P = .0018).
This effect was observed regardless of the PD-L1 expression level of patients’ renal cell tumors, according to a Nov. 23 statement issued by the FDA.
The most common side effects of nivolumab treatment were fatigue, cough, nausea, rash, dyspnea, diarrhea, constipation, decreased appetite, and arthralgia.
The FDA cautioned that nivolumab also has the potential to cause serious immune-mediated side effects.
The FDA granted the nivolumab application a breakthrough therapy designation, fast track designation, and priority review status. Temsirolimus (Torisel), approved in 2007, is the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer, the FDA said.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb.