Cnmpa Approves Agilent'S Pd-L1 Companion Diagnostic
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.

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