The US Food and Drug Administration (FDA) has granted priority review for Merck’s supplemental biologics license application (sBLA) for KEYTRUDA (pembrolizumab) as adjuvant therapy for patients with renal cell carcinoma (RCC).
The latest move follows the receipt of a Complete Response Letter (CRL) from the USFDA for the company’s sBLA for KEYTRUDA , an anti-programmed death receptor-1 (PD-1) therapy, in March this year.
The sBLA allows the use of the therapy for patients at intermediate-high or high risk for recurrence after nephrectomy (surgical removal of a kidney), or after nephrectomy and resection of metastatic lesions.
The FDA approval was based on data obtained from the Phase III KEYNOTE-564 trial, which included 994 patients with RCC who underwent nephrectomy and had intermediate-high risk, high-risk, or M1 no evidence of disease (M1 NED) RCC with clear cell component.
In this trial, KEYTRUDA demonstrated significant improvements in disease-free survival (DFS) compared with placebo.
The FDA has set 10 December this year as a Prescription Drug User Fee Act (PDUFA), or target action.
Merck Research Laboratories clinical research vice president Scot Ebbinghaus said: “The acceptance of our application demonstrates the progress we are making in earlier lines and earlier stages of certain cancers across our oncology portfolio.
“We look forward to working with the FDA towards the goal of bringing the first adjuvant immunotherapy option to appropriate patients with renal cell carcinoma in the U.S.”
The company stated that the therapy in combination with axitinib is currently approved in the US, Japan and Europe for the first-line treatment for patients with advanced RCC.