?????·??|?§??????????????o??o|è???o¤??????A?????????????????? Dako PD-L1 IHC 22C3 pharmDx ????????1?3??????°?·2é??è????????é?????è??????????????????±? (FDA) ???é???o????????±???1??????????????¨?o???????è??è?o?????? GEJ è?o??????è??è????|é????¨ KEYTRUDA??????'??§??????????è??è???2???????KEYTRUDA ???????§? PD-1 ??????????3??????±é??????????????Kenilworth, N.J., USA???????????????????¤§?1??¤??????????/??°??o?§°??oé???2??????????é?????????????a??¨??-???????????????

FDA ??¨ 9 ??? 22 ?????????????·2??1??? KEYTRUDA ??¨?o??2?????¤??????§?±?é?¨?????????è???§???§è??è?o??????è??é???????????é?¨ (GEJ) è?o?????????è?????é??è?? FDA ??1??????????????1?3??????????è???o?è????¤??·??? PD-L1 è?¨è???????????é?3??§?????? (CPS) a?? 1???????1???¨?????????è???o??o?????¤??o??2????????????o??°??????è???±?????2?????????????????°???§??????é???±?è???????????????????? HER2/neu é??????2????????|?é????¨??????PD-L1 IHC 22C3 pharmDx ??? KEYTRUDA ???é???o????????±???1???????????3???è???o????è????°??¨?????????é????? PD-L1 ???????2??????????è????§???

è??????????¨???????o??¤§???è§??????§è????¤????1??????????????-??o???????????¤§???è§??????????è????-??oè??????????????IV ?????????è?????é?????è???·?????????? 4% ??????è??è????°?o? 5 ?1'????-????*???è????????é????1è??è?o?????? GEJ è?o??????è??????2??????1???????°?????????-è????????é???????§?????????

PD-L1 IHC 22C3 pharmDx?o?2015 ?1' 10 ???????????oé|???aè?·????????? FDA ??1????????¨?o??????? NSCLC ???è????? PD-L1 è?¨è???°'?13???????????1?3??????°??¨???????1????é|???aè?· FDA è?¤è?????è??è?o?????? GEJ è?o??????è?? PD-L1 è?¨è???°'?13???????????1?3?????????¨?o??????????è??è????|?????? PD-1 ??????????3? KEYTRUDA ????2???????

?????·??|è????-?????o???????-|?o????é?¨???è?? Jacob Thaysen è°?é?????a???????????è???1??????? FDA è???¤???1??? PD-L1 IHC 22C3 pharmDx ????????1?3?é???o???????????±??o???¨???è????1?3??????oè???????? GEJ ??????è?????è??è??è????¤??·?????? PD-L1 è?¨è?????è???????????????????????è????|?????? KEYTRUDA ????2???????????o????è?????a??

KEYNOTE-059 è??éa???-???è????|?????? KEYTRUDA ?2???????è????? PD-L1 è?¨è???°'?13???è????°????????±PD-L1 IHC 22C3 pharmDx ????????????KEYNOTE-059 ??????é?1?3¨???2 ????????¨?????§?¤???-??????é??é????o???é????2??§????¤????è??éa??????¨?o??????? KEYTRUDA ??1??????è??è?o?????? GEJ è?o??????è??????2?????????????

PD-L1 IHC 22C3 pharmDx ????????·??|???é??????????? (Kenilworth, NJ, USA) ????????????????o§?????????è????? PD-1 ??????????3? KEYTRUDA ??????é????????

KEYTRUDA ???????§??oo?o??????????é??????????????é??è???????o?oo?????????????????°?????1???è????¤???è?????KEYTRUDA é????-?o? PD-1?????????é????? PD-L1 ?????? PD-L2 ?1?é?'???????o??????¨??????è??????'??o????????????±???è????¤???è?????????o·???è????? T ?·??·'???è?????

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