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  • FDA grants priority review to sBLA for Keytruda as...

FDA grants priority review to sBLA for Keytruda as adjuvant therapy in certain patients with renal cell carcinoma

Read time: 1 mins
Published:11th Aug 2021
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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