Category: Approval/Launch Region: North America Company: Agilent Technologies Inc

Cnmpa Approves Agilent'S Pd-L1 Companion Diagnostic

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.

Found this useful? Share it with your team.

Welcome Back Sign in to Continue

Don't Have an Account? Sign Up!
Forgot Password?

Create your Account!

Don't Have an Account? Sign Up!