Posted by Michael Wonder on 10 Aug 2021
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) as adjuvant therapy in certain patients with renal cell carcinoma following surgery
10 August 2021 - Application based on KEYNOTE-564, a Phase 3 trial that evaluated adjuvant immunotherapy in renal cell carcinoma.
Merck today announced that the U.S. FDA has accepted and granted priority review for a new supplemental biologics license application for Keytruda for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
This application is based on data from the pivotal Phase 3 KEYNOTE-564 trial, in which Keytruda demonstrated a statistically significant and clinically meaningful improvement in disease-free survival compared to placebo.
The FDA has set a Prescription Drug User Fee Act, or target action, date of 10 December 2021.
