Agilent Technologies has announced that the National Medical Products Administration (NMPA, formerly the China Food and Drug Administration) has approved its PD-L1 IHC 22C3 pharmDx assay for use in China.
The assay is now approved as a companion diagnostic to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] >1%) for first-line treatment with single-agent KEYTRUDA, an anti-PD-1 therapy manufactured by Merck & Co., Inc. Kenilworth, NJ, U.S.A.
Lung cancer accounts for 20% of all cancer deaths in China and is the leading cause of cancer death there1. NMPA approved the assay to identify advanced NSCLC patients whose tumors express PD-L1 Tumor Proportion Score (TPS) ≥ 1% for first-line treatment with KEYTRUDA monotherapy. KEYTRUDA, as monotherapy, recently received NMPA approval for first-line treatment of patients with locally advanced or metastatic NSCLC whose tumors express PD-L1 TPS ≥ 1% as determined by a validated test.
KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1, and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells. KEYTRUDA and other targeted immunotherapies are revolutionizing cancer treatment, and their therapeutic value is being demonstrated in NSCLC.