Merck: FDA Grants Priority Review To SBLA For KEYTRUDA As Adjuvant Immunotherapy In RCC

(RTTNews) - Merck (MRK) said the FDA has accepted and granted priority review for a new supplemental Biologics License Application for KEYTRUDA as adjuvant therapy in certain patients with Renal Cell Carcinoma following surgery. The sBLA is based on data from the pivotal Phase 3 KEYNOTE-564 trial. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of December 10, 2021.

KEYTRUDA, Merck's anti-PD-1 therapy, is currently approved in the U.S., Europe and Japan in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma.