The European Medicines Agency's (EMA) drug review panel has recommended extending the use of the immunotherapy nivolumab (Opdivo, Bristol-Myers Squibb) to include the treatment of patients with advanced renal cell carcinoma who have received previous therapy.
This use covers both metastatic and unresectable locally advanced kidney cancers.
The kidney cancer indication for nivolumab is already approved in the United States.
The same panel — the Committee for Medicinal Products for Human Use (CHMP) — also recommended the approval of nivolumab for use in advanced nonsquamous non-small-cell lung cancer (NSCLC); it is already approved in Europe for use in advanced squamous NSCLC and in advanced melanoma.
Nivolumab is already approved for all these indications in the United States. The kidney cancer indication was approved by the US Food and Drug Administration in November 2015
Demonstrated Survival Benefit
The recommendation for use in renal cell carcinoma was based on results from a randomized phase 3 study known as CheckMate 025, first presented in September 2015 at the European Cancer Congress, as reported by Medscape Medical News, and published simultaneously in the New England Journal of Medicine (N Engl J Med. 2015; 373:1803-1813).
In that study, 821 patients with advanced renal cell carcinoma who had stopped responding to antiangiogenic therapies were randomly assigned to receive nivolumab or everolimus (Afinitor, Novartis), a standard therapy in this setting.
Median overall survival was better with nivolumab than with everolimus (25.0 vs 19.6 months; hazard ratio, 0.73; P = .002).
In addition, more patients responded to the immunotherapy; the objective response rate was 21.5% for nivolumab and 3.9% for everolimus. On average, the effect lasted around 12 months in both groups.
"Nivolumab has set a new benchmark," meeting discussant Cora Sternberg, MD, from the San Camillo-Forlanini Hospital in Rome, said at the time.
Nivolumab is the new standard of care in second-line therapy for advanced renal cell carcinoma, experts wrote in an editorial that accompanied the publication of the results (N Engl J Med. 2015;373:1872-1874).
"Given the overall survival advantage it confers and its relatively good side-effect profile, nivolumab is the choice for patients who have disease progression while they are receiving [vascular endothelial growth-factor]-targeted therapy," wrote David Quinn, MD, PhD, from the University of Southern California Norris Comprehensive Cancer Center in Los Angeles, and Primo Lara Jr, MD, from the University of California, Davis Comprehensive Cancer Center in Sacramento.
In CheckMate 025, grade 3 or 4 treatment-related adverse events were less common in the nivolumab group than in the everolimus group (19% vs 37%). The most common adverse event in the nivolumab group was fatigue (in 2% of the patients).
The other common adverse effects related to nivolumab are cough, nausea, rash, dyspnea, diarrhea, constipation, decreased appetite, back pain, and arthralgia, according to the CheckMate 025 data.
Nivolumab can also cause serious immune-mediated adverse effects in the lungs, colon, liver, kidneys, hormone-producing glands, and the brain, according to investigators.
In other EMA news, the CHMP also recommended the approval of an oral therapy that combines trifluridine and tipiracil (Lonsurf, Taiho Oncology) in the treatment of metastatic colorectal cancer.
Also, the generic medicine Palonosetron Hospira (palonosetron) received a positive recommendation from the CHMP for the prevention of nausea and vomiting associated with chemotherapy.