Agi­lent re­ceives ap­proval for urothe­lial car­ci­noma as­say

BioSpectrum (India) - - SUPPLIER NEWS -

Agi­lent Tech­nolo­gies Inc. has re­cently an­nounced that the U.S. Food and Drug Ad­min­is­tra­tion (FDA) has ap­proved its Dako PD-L1 IHC 22C3 phar­mDx as­say for ex­panded use in urothe­lial car­ci­noma. The as­say is now ap­proved to iden­tify pa­tients with urothe­lial car­ci­noma who may ben­e­fit from KEYTRUDA, an anti-PD-1 ther­apy man­u­fac­tured by Merck (known as MSD out­side the United States and Canada), as a first-line treat­ment op­tion. KEYTRUDA is ap­proved for pa­tients with lo­cally ad­vanced or metastatic urothe­lial car­ci­noma who are not el­i­gi­ble for cis­platin-con­tain­ing chemo­ther­apy and whose tu­mors ex­press PD-L1 [Com­bined Pos­i­tive Score (CPS) ≥ 10] as de­ter­mined by an FDA-ap­proved test, or in pa­tients who are not el­i­gi­ble for any plat­inum­con­tain­ing chemo­ther­apy re­gard­less of PD-L1 sta­tus. PD-L1 IHC 22C3 phar­mDx is the only FDA-ap­proved com­pan­ion di­ag­nos­tic to iden­tify pa­tients with urothe­lial car­ci­noma for treat­ment with KEYTRUDA. This fol­lows pre­vi­ous FDA ap­provals for PD-L1 IHC 22C3 phar­mDx in non-small cell lung cancer (NSCLC), gas­tric or gas­troe­sophageal junc­tion (GEJ) ade­no­car­ci­noma, and cer­vi­cal cancer.

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