Findings from Food and Drug Administration Provide New Insights into Carcinomas (FDA Approval Summary: Nivolumab in Advanced Renal Cell Carcinoma After Anti-Angiogenic Therapy and Exploratory Predictive Biomarker Analysis)
By a News Reporter-Staff News Editor at Medical Letter on the CDC & FDA Current study results on Oncology - Carcinomas have been published. According to news reporting out of Silver Spring, Maryland, by NewsRx editors, research stated, "On November 23, 2015, the U.S. Food and Drug Administration approved nivolumab (OPDIVO, Bristol-Myers Squibb Company) for patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy."
Our news journalists obtained a quote from the research from Food and Drug Administration, "The approval was based on efficacy and safety data demonstrated in an open-label, randomized study of 821 patients with advanced RCC who progressed after at least one anti-angiogenic therapy. Patients were randomized to nivolumab or everolimus and followed for disease progression. The primary end point was overall survival. Subsequent therapies, including everolimus for patients who developed progressive disease on the nivolumab arm, were allowed, but no cross-over was permitted. The median overall survival was 25.0 months on the nivolumab arm and 19.6 months on everolimus arm (hazard ratio: 0.73; 95% confidence interval: 0.60-0.89). The confirmed response rates were 21.5% versus 3.9%; median durations of response were 23.0 versus 13.7 months, and median times to response were 3.0 versus 3.7 months in the nivolumab and everolimus arms, respectively. A statistically significant improvement in progression-free survival was not observed in this trial. The safety profile of nivolumab in renal cell cancer was similar to that in other disease settings."
According to the news editors, the research concluded: "However, the incidence of immune-mediated nephritis appeared to be higher in patients with RCC."
For more information on this research see: FDA Approval Summary: Nivolumab in Advanced Renal Cell Carcinoma After Anti-Angiogenic Therapy and Exploratory Predictive Biomarker Analysis. Oncologist, 2017;22(3):311-317. Oncologist can be contacted at: Wiley, 111 River St, Hoboken 07030-5774, NJ, USA (see also Oncology - Carcinomas).
Our news journalists report that additional information may be obtained by contacting J.X. Xu, Food & Drug Administration, Center Drug Evaluat & Res, Silver Spring, MD, United States. Additional authors for this research include V.E. Maher, L.J. Zhang, S.H. Tang, R. Sridhara, A. Ibrahim, G. Kim and R. Pazdur.
Keywords for this news article include: Silver Spring, Maryland, United States, North and Central America, Tyrosine Kinase Inhibitors, Immunosuppressive Agents, MTOR Kinase Inhibitors, Renal Cell Carcinoma, Drugs and Therapies, Antineoplastics, MTOR Inhibitors, Angiogenesis, Nephrology, Everolimus, Carcinomas, Oncology, Therapy, Kidney, Food and Drug Administration.
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