FDA Grants Priority Review to Pembrolizumab as Adjuvant Therapy After Nephrectomy
Posted: Friday, August 13, 2021
On August 10, the U.S. Food and Drug Administration (FDA) granted Priority Review to a new supplemental biologics license application for pembrolizumab as an adjuvant treatment for certain patients with renal cell carcinoma. Pembrolizumab is intended to treat patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. The anti–PD-1 therapy has received prior approval for first-line treatment of patients with advanced renal cell carcinoma when combined with axitinib.
The decision for Priority Review comes after the FDA reviewed data from the double-blind phase III KEYNOTE-564 clinical trial. The study investigated pembrolizumab monotherapy for the adjuvant treatment in 994 patients with renal cell carcinoma who had a prior nephrectomy as well as have intermediate-high risk, high risk, or M1 no evidence of disease renal cell carcinoma with a clear cell component. The patients received either 200 mg of pembrolizumab intravenously on day 1 of each 3-week cycle for up to 17 cycles or a placebo.
The results showed a statistically significant and clinically meaningful improvement in disease-free survival when patients were given pembrolizumab compared with a placebo. For more information on the study data, visit meetinglibrary.asco.org.