{"id":4728,"date":"2022-10-31T02:57:29","date_gmt":"2022-10-31T02:57:29","guid":{"rendered":"https:\/\/aceoncology.org\/?p=4728"},"modified":"2023-05-24T09:41:34","modified_gmt":"2023-05-24T09:41:34","slug":"fda-new-cancer-indications-approvals-september-2022","status":"publish","type":"post","link":"https:\/\/aceoncology.org\/zh-hans\/fda-new-cancer-indications-approvals-september-2022\/","title":{"rendered":"2022\u5e749\u6708FDA\u6279\u51c6\u7684\u80bf\u7624\u7597\u6cd5"},"content":{"rendered":"\n<p>2022\u5e749\u6708\u7f8e\u56fdFDA\u5171\u6279\u51c6\u4e865\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Futibatinib\u83b7\u6279\u7528\u4e8e\u8f6c\u79fb\u6027\u80c6\u7ba1\u764c<\/strong>\u3002\u9ad8\u9009\u62e9\u6027\u3001\u4e0d\u53ef\u9006 FGFR1-4 \u6291\u5236\u5242futibatinib\uff08Lytgobi\uff0c\u5927\u9e4f\u5236\u836f\uff09\u83b7\u5f97<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-futibatinib-cholangiocarcinoma\">\u52a0\u901f\u6279\u51c6<\/a>\uff0c\u7528\u4e8e\u6cbb\u7597\u7ecf\u6cbb\u7684\u6210\u7ea4\u7ef4\u7ec6\u80de\u751f\u957f\u56e0\u5b50\u53d7\u4f53 2\uff08FGFR2\uff09\u57fa\u56e0\u878d\u5408\/\u91cd\u6392\u7684\u4e0d\u53ef\u5207\u9664\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u809d\u5185\u80c6\u7ba1\u764c\uff08iCCA\uff09\u6210\u4eba\u60a3\u8005\u3002\u8be5\u6279\u51c6\u662f\u57fa\u4e8e\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6027\u3001\u5355\u81c2 <a href=\"https:\/\/ascopubs.org\/doi\/abs\/10.1200\/JCO.2022.40.16_suppl.4009%20\">TAS-120-101\uff08FOENIX-CCA2\uff09 \u7814\u7a76<\/a>\u7684\u7597\u6548\u7ed3\u679c\uff0c\u8be5\u7814\u7a76\u7eb3\u5165\u4e86103\u4f8b\u7ecf\u4e8c\u4ee3\u6d4b\u5e8f\uff08NGS\uff09\u68c0\u6d4b\u5230 FGFR2 \u878d\u5408\/\u91cd\u6392\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027 iCCA \u60a3\u8005\u3002\u5728\u4e3b\u8981\u5206\u6790\u65f6\uff0c\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a 41.7%\uff0c\u4e2d\u4f4d\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DoR\uff09\u4e3a 9.7 \u4e2a\u6708\u3002\u989d\u5916\u968f\u8bbf 8 \u4e2a\u6708\uff0825 \u4e2a\u6708\uff09\u540e\u7684\u5206\u6790\u8bc1\u5b9e\u4e86\u5728\u65e2\u5f80\u63a5\u53d7\u8fc7\u6cbb\u7597\u7684\u643a\u5e26 FGFR2 \u878d\u5408\/\u91cd\u6392\u7684\u665a\u671f iCCA \u60a3\u8005\u4e2d\u89c2\u5bdf\u5230\u7684 futibatinib \u6301\u4e45\u7597\u6548\u548c\u6301\u7eed\u8010\u53d7\u6027\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c74% \u7684\u7f13\u89e3\u6301\u7eed6\u4e2a\u6708\u6216\u66f4\u957f\u65f6\u95f4\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u5ea6\u4f10\u5229\u5c24\u5355\u6297\u7528\u4e8e\u8f6c\u79fb\u6027\u80c6\u9053\u80bf\u7624<\/strong>\u3002\u5ea6\u4f10\u5229\u5c24\u5355\u6297\uff08\u82f1\u98de\u51e1\uff0c\u82f1\u56fd\u963f\u65af\u5229\u5eb7\uff09\u8054\u5408\u5409\u897f\u4ed6\u6ee8\u548c\u987a\u94c2<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-durvalumab-locally-advanced-or-metastatic-biliary-tract-cancer\">\u83b7\u6279<\/a>\u7528\u4e8e\u6cbb\u7597\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u80c6\u9053\u80bf\u7624\uff08BTC\uff09\u6210\u4eba\u60a3\u8005\u3002\u6b64\u6b21\u6279\u51c6\u662f\u57fa\u4e8e\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001\u968f\u673a\u3001III\u671f<a href=\"https:\/\/evidence.nejm.org\/doi\/abs\/10.1056\/EVIDoa2200015\"> TOPAZ-1 \u7814\u7a76 <\/a>\uff08n = 685\uff09\uff0c\u8be5\u7814\u7a76\u5728\u65e2\u5f80\u672a\u7ecf\u6cbb\u7597\u7684\u665a\u671f BTC \u60a3\u8005\u4e2d\u6bd4\u8f83\u4e86\u5ea6\u4f10\u5229\u5c24\u5355\u6297\u8054\u5408\u5316\u7597\uff08\u5409\u897f\u4ed6\u6ee8\u8054\u5408\u987a\u94c2\uff09\u4e0e\u5b89\u6170\u5242\u8054\u5408\u5316\u7597\uff08\u60a3\u8005\u5305\u62ec 56% \u80c6\u7ba1\u764c\uff0c25% \u80c6\u56ca\u764c\uff0c19% \u5408\u5e76\u809d\u5916\u80c6\u7ba1\u764c\uff09\u3002\u5ea6\u4f10\u5229\u5c24\u5355\u6297\u7ec4\u548c\u5b89\u6170\u5242\u7ec4\u7684\u4e2d\u4f4d\u603b\u751f\u5b58\u671f\uff08OS\uff09\u5206\u522b\u4e3a 12.8 \u4e2a\u6708\u548c 11.5 \u4e2a\u6708\uff08\u98ce\u9669\u6bd4[HR]\uff0c0.80\uff1bP = 0.021\uff09\u3002\u5ea6\u4f10\u5229\u5c24\u5355\u6297\u7ec4\u548c\u5b89\u6170\u5242\u7ec4\u7684\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u5206\u522b\u4e3a 7.2 \u4e2a\u6708\u548c 5.7 \u4e2a\u6708\uff0c\u7814\u7a76\u8005\u8bc4\u4f30\u7684 ORR \u5206\u522b\u4e3a 27% \u548c 19%\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u585e\u666e\u66ff\u5c3c\u83b7\u6279\u7528\u4e8eRET\u878d\u5408\u9633\u6027\u665a\u671fNSCLC<\/strong>\u3002\u585e\u666e\u66ff\u5c3c\uff08Retevmo\uff0c\u793c\u6765\u516c\u53f8\uff09<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive-non-small-cell-lung\">\u83b7\u6279<\/a>\u7528\u4e8e\u6cbb\u7597\u643a\u5e26 RET \u57fa\u56e0\u878d\u5408\u7684\u665a\u671f\u975e\u5c0f\u7ec6\u80de\u80ba\u764c \uff08NSCLC\uff09 \u6210\u4eba\u60a3\u8005\uff08\u57fa\u4e8e FDA \u6279\u51c6\u7684\u8bd5\u9a8c\u68c0\u6d4b\uff09\u3002\u585e\u666e\u66ff\u5c3c\u6b64\u524d\u5df2\u4e8e 2020 \u5e74 5 \u6708\u83b7\u5f97\u8be5\u9002\u5e94\u75c7\u7684\u52a0\u901f\u5ba1\u6279\u3002\u6700\u521d\u7684\u83b7\u6279\u662f\u57fa\u4e8e\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6027<a href=\"https:\/\/www.nejm.org\/doi\/10.1056\/NEJMoa2005653\"> LIBRETTO-001 \u7814\u7a76<\/a>\u7684\u521d\u59cb ORR \u548c DoR \u7ed3\u679c\uff0c\u8be5\u7814\u7a76\u7eb3\u5165\u4e86 144 \u4f8b\u60a3\u8005\u3002\u5e38\u89c4\u6279\u51c6\u7684\u66f4\u65b0\u662f\u57fa\u4e8e\u53e6\u5916 172 \u4f8b\u60a3\u8005\u8fdb\u4e00\u6b65 18 \u4e2a\u6708\u968f\u8bbf\u7684<a href=\"https:\/\/ascopubs.org\/doi\/full\/10.1200\/JCO.22.00393\">\u6570\u636e<\/a>\uff0c\u5171\u5f97\u5230316\u4f8b\u60a3\u8005\u3002\u572869\u4f8b\u521d\u6cbb\u60a3\u8005\u4e2d\uff0cORR \u4e3a 84%\uff0cDoR \u4e3a 20.2 \u4e2a\u6708\u3002\u5728 247 \u4f8b\u65e2\u5f80\u63a5\u53d7\u94c2\u7c7b\u836f\u7269\u5316\u7597\u7684\u60a3\u8005\u4e2d\uff0cORR \u4e3a 61%\uff0cDoR \u4e3a 28.6\u4e2a\u6708\u3002FDA \u8fd8\u6279\u51c6 Oncomine\u2122Dx Target Test\uff08\u8d5b\u9ed8\u98de\u4e16\u5c14\u79d1\u6280\uff09\u4f5c\u4e3a\u585e\u666e\u66ff\u5c3c\u7684\u4f34\u968f\u8bca\u65ad\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u585e\u666e\u66ff\u5c3c\u83b7\u6279\u7528\u4e8eRET\u878d\u5408\u9633\u6027\u665a\u671f\u5b9e\u4f53\u7624<\/strong>\u3002\u585e\u666e\u66ff\u5c3c\u8fd8\u83b7\u5f97\u4e86<a href=\"FDA%20approves%20selpercatinib%20for%20locally%20advanced%20or%20metastatic%20RET%20fusion-positive%20solid%20tumors%20|%20FDA%20\">\u52a0\u901f\u5ba1\u6279<\/a>\uff0c\u7528\u4e8e\u65e2\u5f80\u5168\u8eab\u6cbb\u7597\u671f\u95f4\u6216\u6cbb\u7597\u540e\u8fdb\u5c55\u7684\u643a\u5e26RET \u57fa\u56e0\u878d\u5408\u7684\u665a\u671f\u5b9e\u4f53\u7624\u60a3\u8005\uff0c\u6216\u65e0\u6ee1\u610f\u66ff\u4ee3\u6cbb\u7597\u9009\u62e9\u7684\u60a3\u8005\u3002\u6b64\u6b21\u6279\u51c6\u662f\u57fa\u4e8e\u5bf9<a href=\"https:\/\/www.thelancet.com\/journals\/lanonc\/article\/PIIS1470-2045(22)00541-1\/fulltext\"> LIBRETTO-001 \u7bee\u5b50\u7814\u7a76<\/a>\u7684 ORR \u548c DoR \u6570\u636e\u7684\u4e2d\u671f\u5206\u6790\uff0c\u8be5\u7814\u7a76\u5165\u7ec4\u4e8645\u4f8b\u65e2\u5f80\u5168\u8eab\u6cbb\u7597\u671f\u95f4\u6216\u6cbb\u7597\u540e\u75be\u75c5\u8fdb\u5c55\u6216\u65e0\u6ee1\u610f\u66ff\u4ee3\u6cbb\u7597\u9009\u62e9\u7684 RET \u878d\u5408\u9633\u6027\u80bf\u7624\uff08NSCLC \u548c\u7532\u72b6\u817a\u764c\u9664\u5916\uff09\u60a3\u8005\u3002\u5728 41 \u4f8b\u7597\u6548\u53ef\u8bc4\u4ef7\u60a3\u8005\u4e2d\uff0c\u72ec\u7acb\u5ba1\u67e5\u59d4\u5458\u4f1a\u8bc4\u4f30\u7684 ORR \u4e3a 43.9%\uff08n = 18\uff09\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u786b\u4ee3\u786b\u9178\u94a0\u83b7\u6279\u7528\u4e8e\u964d\u4f4e\u987a\u94c2\u5728\u513f\u7ae5\u5c40\u90e8\u5b9e\u4f53\u7624\u60a3\u8005\u4e2d\u7684\u8033\u6bd2\u6027\u98ce\u9669<\/strong>\u3002\u786b\u4ee3\u786b\u9178\u94a0 \uff08Pedmark\uff0cFennec\u5236\u836f\uff09 <a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-sodium-thiosulfate-reduce-risk-ototoxicity-associated-cisplatin-pediatric-patients\">\u83b7\u6279<\/a>\u7528\u4e8e\u964d\u4f4e 1 \u4e2a\u6708\u53ca\u4ee5\u4e0a\u5c40\u9650\u6027\u3001\u975e\u8f6c\u79fb\u6027\u5b9e\u4f53\u7624\u513f\u7ae5\u60a3\u8005\u987a\u94c2\u76f8\u5173\u7684\u8033\u6bd2\u6027\u98ce\u9669\u3002\u5728\u4e24\u9879\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6807\u7b7e\u3001\u968f\u673a\u5bf9\u7167\u7814\u7a76 SIOPEL 6 \u548c COG ACCL0431 \u4e2d\u8bc4\u4ef7\u4e86\u7597\u6548\uff0c\u4e24\u9879\u7814\u7a76\u7eb3\u5165\u4e86\u63a5\u53d7\u4ee5\u987a\u94c2\u4e3a\u57fa\u7840\u5316\u7597\u7684\u513f\u79d1\u60a3\u8005\u3002\u5728 <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/nejmoa1801109%20\">SIOPEL 6 \u7814\u7a76 <\/a>\u4e2d\uff0c114 \u4f8b\u809d\u6bcd\u7ec6\u80de\u7624\u60a3\u513f\u63a5\u53d7\u4e86 6 \u4e2a\u5468\u671f\u7684\u56f4\u624b\u672f\u671f\u987a\u94c2\u8054\u5408\u6216\u4e0d\u8054\u5408\u4e0d\u540c\u5242\u91cf\u7684\u786b\u4ee3\u786b\u9178\u94a0\u6cbb\u7597\u3002\u4e3b\u8981\u7ed3\u5c40\u662f Brock\u22651 \u7ea7\u542c\u529b\u4e27\u5931\u7684\u60a3\u8005\u767e\u5206\u6bd4\u3002\u4e0e\u987a\u94c2\u5355\u836f\u7ec4 \uff0868%\uff09 \u76f8\u6bd4\uff0c\u786b\u4ee3\u786b\u9178\u94a0\u548c\u987a\u94c2\u7ec4 \uff0839%\uff09 \u7684\u542c\u529b\u4e27\u5931\u53d1\u751f\u7387\u8f83\u4f4e\uff0c\u672a\u6821\u6b63\u7684\u76f8\u5bf9\u98ce\u9669\u4e3a0.58\u3002\u5728 COG ACCL0431 \u7814\u7a76\u4e2d\uff0c125\u4f8b\u5b9e\u4f53\u7624\u60a3\u8005\uff081-18\u5c81\uff09\u63a5\u53d7\u4e86\u4ee5\u987a\u94c2\u4e3a\u57fa\u7840\u7684\u5316\u7597\uff08\u987a\u94c2\u7d2f\u79ef\u5242\u91cf \u2265 200 mg\/m2\uff09\uff0c\u8054\u5408\u6216\u4e0d\u8054\u5408\u786b\u4ee3\u786b\u9178\u94a0\u3002\u5728 77 \u4f8b\u5c40\u90e8\u3001\u975e\u8f6c\u79fb\u6027\u5b9e\u4f53\u7624\u60a3\u8005\u4e9a\u7ec4\u4e2d\u8bc4\u4ef7\u4e86\u7597\u6548\u3002\u6839\u636e\u7f8e\u56fd\u8a00\u8bed\u8bed\u8a00\u542c\u529b\u534f\u4f1a\u6807\u51c6\uff0c\u4e0e\u987a\u94c2\u5355\u836f\u7ec4 \uff0858%\uff09 \u76f8\u6bd4\uff0c\u786b\u4ee3\u786b\u9178\u94a0\u52a0\u987a\u94c2\u7ec4 \uff0844%\uff09 \u542c\u529b\u4e27\u5931\u7684\u53d1\u751f\u7387\u8f83\u4f4e\uff0c\u672a\u6821\u6b63\u7684\u76f8\u5bf9\u98ce\u9669\u4e3a 0.75\u3002\u63a8\u8350\u7684\u786b\u4ee3\u786b\u9178\u94a0\u5242\u91cf\u662f\u6839\u636e\u5b9e\u9645\u4f53\u91cd\u7684\u8868\u9762\u79ef\u800c\u5b9a\u3002\u5728\u987a\u94c2\u8f93\u6ce8\u540e 15 \u5206\u949f\u5185\u9759\u8109\u8f93\u6ce8\u786b\u4ee3\u786b\u9178\u94a0\uff0c\u6301\u7eed\u65f6\u95f4\u4e3a 1-6 \u5c0f\u65f6\u3002<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>2022\u5e749\u6708\u7f8e\u56fdFDA\u5171\u6279\u51c6\u4e865\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5\u3002 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