News
FDA grants priority review to sBLA for Keytruda as adjuvant therapy in certain patients with renal cell carcinoma
Merck announced that the FDA has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for Keytruda, Merck’s anti-PD-1 therapy, for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy (surgical removal of a kidney), or following nephrectomy and resection of metastatic lesions.
This sBLA is based on data from the pivotal Phase III KEYNOTE-564 trial, in which Keytruda demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) compared to placebo. These data were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of December 10, 2021.
Condition: Renal Cell Carcinoma
Type: drug
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