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瀹為獙瀹よ祫璁綉

缇庡浗椋熻嵂鐩戝眬姝e紡鎵瑰噯璇哄崕鍏徃CAR-T鐤楁硶锛岀郴鍏ㄧ悆棣栦緥

瀹為獙瀹よ祫璁綉鏃堕棿:2017-09-01 鐐瑰嚮: 娆?/span> 鐧惧害鎼滅储

銆愬璇汇€?/strong>鎹編鍥介鍝佸拰鑽搧绠$悊灞€锛團DA锛夊畼缃?鏈?0鏃ユ秷鎭紝璇哄崕鍏徃鐨凜AR-T鐤楁硶Kymriah锛坱isagenlecleucel锛夋寮忚幏鎵癸紝杩欎篃鎴愪负鍏ㄧ悆棣栦釜鑾锋壒鐨凜AR-T鐤楁硶銆?Kymriah鐢ㄤ簬娌荤枟3宀?25宀佺殑鎬ユ€ф穻宸寸粏鑳炵櫧琛€鐥呯殑澶嶅彂......
TAG鏍囩锛?FDA 璇哄崕 CaR-T CAR-T鐤楁硶 缇庡浗椋熻嵂鐩戝眬 姝e紡鎵瑰噯 璇哄崕鍏徃

缇庡浗椋熻嵂鐩戝眬姝e紡鎵瑰噯璇哄崕鍏徃CAR-T鐤楁硶锛岀郴鍏ㄧ悆棣栦緥

鎹編鍥介鍝佸拰鑽搧绠$悊灞€锛團DA锛夊畼缃?鏈?0鏃ユ秷鎭紝璇哄崕鍏徃鐨凜AR-T鐤楁硶Kymriah锛坱isagenlecleucel锛夋寮忚幏鎵癸紝杩欎篃鎴愪负鍏ㄧ悆棣栦釜鑾锋壒鐨凜AR-T鐤楁硶銆?nbsp;

Kymriah鐢ㄤ簬娌荤枟3宀?25宀佺殑鎬ユ€ф穻宸寸粏鑳炵櫧琛€鐥呯殑澶嶅彂鎬ф垨闅炬不鎬ф偅鑰呫€傝鍗庡叕鍙告槸涓€瀹舵€婚儴浣嶄簬鐟炲+宸村灏旂殑鍒惰嵂鍙婄敓鐗╂妧鏈法鍥藉叕鍙搞€?nbsp;

“Kymriah鏄悓绫婚娆剧殑鐤楁硶锛屾弧瓒充簡缃规偅杩欑涓ラ噸鐤剧梾鐨勫効绔ュ強闈掑勾鐨勯噸瑕侀渶姹傦紝”缇庡浗FDA鐢熺墿鍒跺搧璇勪及鍜岀爺绌朵腑蹇冿紙CBER锛夎礋璐d汉Peter Marks鍗氬+璇撮亾锛?ldquo;Kymriah涓嶄粎璁╄繖浜涘師鏈嚑涔庢棤鑽彲娌荤殑鎮h€呰繋鏉ヤ簡鍏ㄦ柊鐨勬不鐤楁柟妗堬紝杩樺湪涓村簥璇曢獙涓桨鏄句簡鍏呮弧娼滃姏鐨勭紦瑙e拰鐢熷瓨鐜囥€?rdquo; 

涓婅堪瀹樼綉娑堟伅绉帮紝鍦ㄦ潈琛′簡鏀剁泭銆侀闄╁悗锛岀編鍥紽DA鍐冲畾鎵瑰噯瀹冿紝涓虹壒瀹氭偅鑰呯兢浣撳甫鏉ユ柊鐨勬不鐤楀笇鏈涖€?nbsp;

娌冲崡鐪佽偪鐦ゅ尰闄㈢敓鐗╂不鐤楃鐨勪富浠诲尰甯堥珮鍏ㄧ珛姝ゅ墠鎺ュ彈婢庢箖鏂伴椈閲囪鏃惰В閲婏紝“CAR-T鍊熷姪涓€娆剧粡杩囨敼閫犵殑T缁嗚優锛屽畠姣旇嚜鐒剁姸鎬佷笅鐨凾缁嗚優锛屾潃浼ょ簿搴︽洿楂橈紝鑳芥洿鍑嗙‘鍦版敾鍑绘煇绉嶈偪鐦ょ粏鑳烇紝鍍忓寮广€侰AR鏄氨鏄汉浠汉涓哄湴缁欒繖浜涚粏鑳炴坊鍔?lsquo;鐬勫噯鍣?rsquo;銆?rdquo; 

T缁嗚優鏄汉浣撳唴鍏嶇柅缁嗚優鐨勪竴绉嶏紝鏄汉浣撴姷寰$梾鍘熶镜琚殑澶╃劧闃茬嚎涔嬩竴銆傚ぉ鐒剁殑T缁嗚優鏄?ldquo;鏅€氬叺绉?rdquo;锛岃€孋AR-T鐩稿綋浜?ldquo;鐗圭鍏?rdquo;銆?nbsp;

褰撻亣鍒扮壒瀹氱殑鑲跨槫缁嗚優鏃讹紝琚緭鍏ユ偅鑰呬綋鍐呯殑CAR-T缁嗚優浼氳婵€娲伙紝澶ч噺澧炴畺锛屽苟澶у紑鏉€鎴掞紝鏀诲嚮鍜屾潃姝荤梾鍙樼殑鐧界粏鑳炵瓑鑲跨槫缁嗚優锛岃揪鍒版不鐤楁晥鏋溿€?nbsp;

Kymriah灏辨槸涓€绉岰AR-T缁嗚優銆?nbsp;

涓撴敞鑲跨槫绮惧噯鍖荤枟鐨勫尰鑽鎶€鍏徃鎬濊矾杩殑鍒涘浜虹唺纾婂崥澹鍓嶆浘瀵规編婀冩柊闂昏〃绀猴紝璇哄崕鍏徃鍦ㄦ帹骞垮簲鐢↘ymriah鎶€鏈椂杩樿瑙e喅鏍囧噯鍖栫殑闅鹃锛氬浣曚繚璇佸悓涓€瀹跺叕鍙稿湪涓嶅悓鍖哄煙鐨勫疄楠屽锛岀敓浜у嚭鏉ョ殑缁嗚優锛屼复搴婅兘杈惧埌涓€鑷寸殑娌荤枟姘村噯銆?nbsp;

鎹腑鍥界爺绌跺瀷鍖婚櫌瀛︿細鐢熺墿娌荤枟瀛︿笓涓氬鍛樹細涓讳换濮斿憳銆佽В鏀惧啗鎬诲尰闄㈢敓鍛界瀛﹂櫌鍒嗗瓙鍏嶇柅瀛︾爺绌跺涓讳换闊╀负涓滀粙缁嶏紝灏界Kymriah灞曠幇鍑轰簡鎯婁汉鐨勭枟鏁堬紝浣嗗叾瑙勬ā鐢熶骇鐨勭ǔ瀹氭€с€侀暱鏈熺殑姣掓€э紝浠ュ強甯傚満鐨勮鍙▼搴︾瓑灏氶渶鏃堕棿妫€楠岋紝杩樻湁鐩稿綋闀跨殑涓€娈佃矾瑕佽蛋銆?nbsp;

楂樺叏绔嬩篃琛ㄧず锛孋AR-T浣滀负鍓嶆部鎶€鏈紝鐩墠杩樹笉鏄偪鐦ゆ不鐤楃殑棣栭€夋柟妗堬紝鑰屾槸鎺ㄨ崘搴旂敤鍦ㄤ紶缁熸不鐤楁墜娈靛凡缁忔棤璁″彲鏂界殑閲嶇棁鐥呬緥涓娿€?nbsp;

鑰孠ymriah姝ゅ墠杩橀伃閬囦簡璐圭敤鐨勪簤璁紝澶栫晫浼拌鎮h€呴渶瑕佹敮浠樻暟鍗佷竾缇庡厓銆?nbsp;

缇庡浗涓€鍚嶇檶鐥囨偅鑰呭ぇ鍗?bull;绫冲垏灏旓紙David Mitchell锛夎嚧淇¤鍗庡叕鍙搁甯墽琛屽畼涔?bull;甯岄棬灏兼柉锛圝oe Jimenez锛夌О锛屽笇鏈涘氨璇ュ叕鍙歌偪鐦ゅ厤鐤不鐤椾骇鍝並ymriah鐨勫叕骞冲畾浠烽棶棰橈紝涓庝粬浼氶潰杩涜璁ㄨ銆?nbsp;

璇哄崕鍏徃鍚戞編婀冩柊闂绘彁渚涚殑澹版槑绉帮紝璇哄崕鍏徃姝e湪鎱庨噸鑰冭檻Kymriah鐨勫悎鐞嗕环鏍硷紝姝e湪鎺㈢储鍩轰簬缁撴灉锛堟不鐤楁晥鏋滐級鐨勫畾浠凤紝杩欏皢淇冭繘鏂板尰鐤楁妧鏈湪鐧岀棁娌荤枟涓婄殑浣跨敤銆?/span>

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