FDA Approves New Keytruda Indication

FDA has approved a new indication for Merck’s Keytruda for 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. The company says the approval is based on data from the pivotal Phase 3 KEYNOTE-564 trial in which Keytruda demonstrated a statistically significant improvement in disease-free survival compared to placebo.

Merck says Keytruda is an anti-programmed death receptor-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. It is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes that may affect both tumor cells and healthy cells. It has multiple FDA-approved indications.