{"id":11704,"date":"2019-06-19T12:55:01","date_gmt":"2019-06-19T05:55:01","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=11704"},"modified":"2019-06-25T16:09:32","modified_gmt":"2019-06-25T09:09:32","slug":"fda-phe-duyet-pembrolizumab-trong-chi-dinh-dieu-tri-buoc-mot-ung-thu-bieu-mo-te-bao-vay-o-dau-co","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/fda-phe-duyet-pembrolizumab-trong-chi-dinh-dieu-tri-buoc-mot-ung-thu-bieu-mo-te-bao-vay-o-dau-co\/","title":{"rendered":"FDA ph\u00ea duy\u1ec7t Pembrolizumab trong ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb b\u01b0\u1edbc m\u1ed9t ung th\u01b0 bi\u1ec3u m\u00f4 t\u1ebf b\u00e0o v\u1ea3y \u1edf \u0111\u1ea7u c\u1ed5"},"content":{"rendered":"<p>Ng\u00e0y 10\/06\/2019, c\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m M\u1ef9 (FDA) \u0111\u00e3 ph\u00ea duy\u1ec7t <strong>Pembrolizumab<\/strong> (KEYTRUDA, Merck &amp; Co., Inc.) trong ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb b\u01b0\u1edbc m\u1ed9t tr\u00ean BN ung th\u01b0 bi\u1ec3u m\u00f4 t\u1ebf b\u00e0o v\u1ea3y \u1edf \u0111\u1ea7u c\u1ed5 (HNSCC \u2013 Head and neck squamous cell carcinoma) giai \u0111o\u1ea1n di c\u0103n ho\u1eb7c t\u00e1i ph\u00e1t kh\u00f4ng ph\u1eabu thu\u1eadt \u0111\u01b0\u1ee3c. Tr\u01b0\u1edbc \u0111\u00f3, n\u0103m 2016, Pembrolizumab \u0111\u00e3 \u0111\u01b0\u1ee3c FDA ph\u00ea duy\u1ec7t l\u00e0 li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb b\u01b0\u1edbc hai trong HNSCC giai \u0111o\u1ea1n t\u00e1i ph\u00e1t hay di c\u0103n \u0111\u00e3 \u0111\u01b0\u1ee3c h\u00f3a tr\u1ecb li\u1ec7u c\u00f3 ch\u1ee9a nh\u00f3m platium.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-11706 aligncenter\" src=\"https:\/\/www.vnras.com\/drug\/wp-content\/uploads\/2019\/06\/Pembrolizumab_2.jpg\" alt=\"Pembrolizumab\" width=\"600\" height=\"600\" title=\"\" srcset=\"https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/06\/Pembrolizumab_2.jpg 600w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/06\/Pembrolizumab_2-280x280.jpg 280w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/06\/Pembrolizumab_2-400x400.jpg 400w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/06\/Pembrolizumab_2-350x350.jpg 350w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/06\/Pembrolizumab_2-100x100.jpg 100w\" sizes=\"auto, (max-width: 600px) 100vw, 600px\" \/><\/p>\n<p>Pembrolizumab \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn trong s\u1eed d\u1ee5ng k\u1ebft h\u1ee3p v\u1edbi nh\u00f3m platium v\u00e0 5-fluorouracil (5-FU) \u0111\u1ed1i v\u1edbi t\u1ea5t c\u1ea3 b\u1ec7nh nh\u00e2n HNSCC; \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u01a1n \u0111\u1ed9c \u0111\u1ed1i v\u1edbi BN c\u00f3 kh\u1ed1i u c\u00f3 b\u1ed9c l\u1ed9 PD-L1 (Combined Positive Score [CPS] \u22651) x\u00e1c \u0111\u1ecbnh b\u1eb1ng test \u0111\u00e1nh gi\u00e1 \u0111\u00e3 \u0111\u01b0\u1ee3c FDA ph\u00ea duy\u1ec7t. \u0110\u1ed3ng th\u1eddi, FDA m\u1edf r\u1ed9ng ch\u1ec9 \u0111\u1ecbnh s\u1eed d\u1ee5ng c\u1ee7a kit PD-L1 IHC 22C3 pharmDx d\u00f9ng \u0111\u1ec3 ch\u1ea9n \u0111o\u00e1n cho nh\u1eefng BN HNSCC \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi pembrolizumab \u0111\u01a1n \u0111\u1ed9c.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-11705 aligncenter\" src=\"https:\/\/www.vnras.com\/drug\/wp-content\/uploads\/2019\/06\/Pembrolizumab_1.jpg\" alt=\"Pembrolizumab\" width=\"600\" height=\"600\" title=\"\" srcset=\"https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/06\/Pembrolizumab_1.jpg 600w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/06\/Pembrolizumab_1-280x280.jpg 280w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/06\/Pembrolizumab_1-400x400.jpg 400w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/06\/Pembrolizumab_1-350x350.jpg 350w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/06\/Pembrolizumab_1-100x100.jpg 100w\" sizes=\"auto, (max-width: 600px) 100vw, 600px\" \/><\/p>\n<p>Ch\u1ea5p thu\u1eadn n\u00e0y d\u1ef1a tr\u00ean nghi\u00ean c\u1ee9u KEYNOTE-048 (NCT02358031), m\u1ed9t th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, ng\u1eabu nhi\u00ean, \u0111a trung t\u00e2m, nh\u00e3n m\u1edf, bao g\u1ed3m ba nh\u00e1nh tr\u00ean 882 BN HNSCC giai \u0111o\u1ea1n di c\u0103n ch\u01b0a \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb h\u1ec7 th\u1ed1ng tr\u01b0\u1edbc \u0111\u00f3 \u0111\u1ed1i v\u1edbi giai \u0111o\u1ea1n di c\u0103n ho\u1eb7c giai \u0111o\u1ea1n ti\u1ebfn tri\u1ec3n kh\u00f4ng ki\u1ec3m so\u00e1t \u0111\u01b0\u1ee3c khi \u0111i\u1ec1u tr\u1ecb t\u1ea1i ch\u1ed7.<\/p>\n<p>K\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o t\u1ea1i h\u1ed9i ngh\u1ecb th\u01b0\u1eddng ni\u00ean ASCO n\u0103m 2019.<\/p>\n<p>K\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u c\u00f3 \u00fd ngh\u0129a trong vi\u1ec7c c\u00e2n nh\u1eafc s\u1eed d\u1ee5ng k\u1ebft h\u1ee3p pembrolizumab v\u1edbi nh\u00f3m platium v\u00e0 5- FU nh\u01b0 l\u00e0 li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb b\u01b0\u1edbc 1 ti\u00eau chu\u1ea9n m\u1edbi cho BN HNSCC giai \u0111o\u1ea1n di c\u0103n ho\u1eb7c t\u00e1i ph\u00e1t.<\/p>\n<p>Nghi\u00ean c\u1ee9u KEYNOTE-048 : BN tham gia nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c chia ng\u1eabu nghi\u00ean v\u00e0o ba nh\u00f3m sau:<\/p>\n<ul>\n<li>Nh\u00f3m ch\u1ec9 s\u1eed d\u1ee5ng pembrolizumab;<\/li>\n<li>Nh\u00f3m s\u1eed d\u1ee5ng k\u1ebft h\u1ee3p pembrolizumab v\u1edbi 5 FU v\u00e0 carboplatin ho\u1eb7c cisplatin;<\/li>\n<li>Nh\u00f3m s\u1eed d\u1ee5ng cetuximab k\u1ebft h\u1ee3p v\u1edbi 5 FU v\u00e0 carboplatin ho\u1eb7c cisplatin.<\/li>\n<\/ul>\n<p>Ph\u00e2n t\u1ea7ng ng\u1eabu nhi\u00ean theo:<\/p>\n<ul>\n<li>M\u1ee9c \u0111\u1ed9 bi\u1ec3u hi\u1ec7n PD-L1 (t\u1ed5ng t\u1ec9 l\u1ec7 \u0111i\u1ec3m c\u1ee7a b\u01b0\u1edbu TPS \u2265 50% ho\u1eb7c &lt;50%)<\/li>\n<li>T\u00ecnh tr\u1ea1ng HPV (Human Papillomavirus) theo ph\u01b0\u01a1ng ph\u00e1p h\u00f3a m\u00f4 mi\u1ec5n d\u1ecbch (IHC \u2013 Immunohistochemistry) p16 (d\u01b0\u01a1ng t\u00ednh hay \u00e2m t\u00ednh)<\/li>\n<li>T\u1ed5ng \u0111i\u1ec3m ECOG (0 hay 1 \u0111i\u1ec3m).<\/li>\n<li>M\u1ee9c \u0111\u1ed9 bi\u1ec3u hi\u1ec7n PD-L1 (TPS v\u00e0 CPS) \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh d\u1ef1a tr\u00ean kit \u0111\u00e1nh gi\u00e1 PD-L1 IHC 22C3 pharmDxT<\/li>\n<li>S\u1ed1ng th\u00eam to\u00e0n b\u1ed9 (OS \u2013 Overall survival) \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 l\u1ea7n l\u01b0\u1ee3t \u0111\u1ed1i v\u1edbi nh\u00f3m BN HNSCC c\u00f3 \u0111i\u1ec3m CPS \u2265 20, nh\u00f3m BN HNSCC c\u00f3 \u0111i\u1ec3m CPS \u2265 1 v\u00e0 qu\u1ea7n th\u1ec3 chung tham gia nghi\u00ean c\u1ee9u, \u0111\u01b0\u1ee3c xem l\u00e0 ti\u00eau ch\u00ed \u0111\u00e1nh gi\u00e1 ch\u00ednh.<\/li>\n<\/ul>\n<p>Th\u1eed nghi\u1ec7m \u0111\u00e3 ch\u1ee9ng minh c\u00f3 s\u1ef1 c\u1ea3i thi\u1ec7n c\u00f3 \u00fd ngh\u0129a th\u1ed1ng k\u00ea th\u1eddi gian s\u1ed1ng th\u00eam to\u00e0n b\u1ed9 \u1edf nh\u00f3m BN s\u1eed d\u1ee5ng pembrolizumab k\u1ebft h\u1ee3p v\u1edbi h\u00f3a tr\u1ecb li\u1ec7u so v\u1edbi nh\u00f3m BN s\u1eed d\u1ee5ng cetuximab k\u1ebft h\u1ee3p v\u1edbi h\u00f3a tr\u1ecb li\u1ec7u.<\/p>\n<p>Trung v\u1ecb OS c\u1ee7a nh\u00f3m b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng pembrolizumab k\u1ebft h\u1ee3p h\u00f3a tr\u1ecb l\u00e0 13 th\u00e1ng,<\/p>\n<p>Trung v\u1ecb OS c\u1ee7a nh\u00f3m b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng cetuximab k\u1ebft h\u1ee3p h\u00f3a tr\u1ecb l\u00e0 10,7 th\u00e1ng (HR 0,77; 95% CI: 0,63-0,93; p = 0,0067).<\/p>\n<p>K\u1ebft qu\u1ea3 n\u00e0y t\u01b0\u01a1ng t\u1ef1 khi ph\u00e2n t\u00edch d\u01b0\u1edbi nh\u00f3m \u0111\u1ed1i v\u1edbi nh\u00f3m BN \u0111i\u1ec3m CPS \u2265 20 (HR 0,69; 95% CI: 0,51-0,94) v\u00e0 nh\u00f3m BN \u0111i\u1ec3m CPS \u2265 1 (HR 0,71; 95% CI: 0,57-0,88).<\/p>\n<p>K\u1ebft qu\u1ea3 c\u1ee7a nghi\u00ean c\u1ee9u c\u0169ng cho th\u1ea5y:<\/p>\n<ul>\n<li>Khi ph\u00e2n t\u00edch d\u01b0\u1edbi nh\u00f3m b\u1ec7nh nh\u00e2n HNSCC c\u00f3 PD\u2011L1 CPS \u22651 v\u00e0 PD-L1 CPS \u226520, c\u00f3 s\u1ef1 c\u1ea3i thi\u1ec7n c\u00f3 \u00fd ngh\u0129a th\u1ed1ng k\u00ea trung v\u1ecb OS c\u1ee7a nh\u00f3m BN s\u1eed d\u1ee5ng \u0111\u01a1n \u0111\u1ed9c pembrolizumab so v\u1edbi nh\u00f3m s\u1eed d\u1ee5ng k\u1ebft h\u1ee3p cetuximab v\u00e0 h\u00f3a tr\u1ecb li\u1ec7u.<\/li>\n<\/ul>\n<p>V\u1edbi nh\u00f3m BN PD\u2011L1 CPS \u22651:<\/p>\n<ul>\n<li>Trung v\u1ecb OS c\u1ee7a BN s\u1eed d\u1ee5ng pembrolizumab \u0111\u01a1n \u0111\u1ed9c l\u00e0 12,3 th\u00e1ng<\/li>\n<li>Trung v\u1ecb OS c\u1ee7a nh\u00f3m BN s\u1eed d\u1ee5ng k\u1ebft h\u1ee3p cetuximab v\u00e0 h\u00f3a tr\u1ecb li\u1ec7u l\u00e0 10,3 th\u00e1ng (HR 0,78; 95% CI: 0,64-0,96; p = 0,0171).<\/li>\n<\/ul>\n<p>V\u1edbi nh\u00f3m BN PD-L1 CPS \u226520:<\/p>\n<ul>\n<li>Trung v\u1ecb OS l\u00e0 14,9 \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng pembrolizumab \u0111\u01a1n \u0111\u1ed9c;<\/li>\n<li>Trung v\u1ecb OS l\u00e0 10,7 th\u00e1ng \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng k\u1ebft h\u1ee3p cetuximab v\u00e0 h\u00f3a tr\u1ecb li\u1ec7u (HR 0,61; 95% CI: 0,45-0,83; p = 0.0015).<\/li>\n<\/ul>\n<p>Trong ph\u00e2n t\u00edch t\u1ea1m th\u1eddi n\u00e0y, k\u1ebft qu\u1ea3 cho th\u1ea5y ch\u01b0a c\u00f3 s\u1ef1 kh\u00e1c bi\u1ec7t \u0111\u00e1ng k\u1ec3 v\u1ec1 OS gi\u1eefa nh\u00f3m s\u1eed d\u1ee5ng \u0111\u01a1n \u0111\u1ed9c pembrolizumab v\u1edbi nh\u00f3m s\u1eed d\u1ee5ng k\u1ebft h\u1ee3p cetuximab v\u00e0 h\u00f3a tr\u1ecb li\u1ec7u tr\u00ean to\u00e0n b\u1ed9 qu\u1ea7n th\u1ec3 BN tham gia nghi\u00ean c\u1ee9u.<\/p>\n<p>Ch\u01b0a c\u00f3 s\u1ef1 kh\u00e1c bi\u1ec7t c\u00f3 \u00fd ngh\u0129a th\u1ed1ng k\u00ea v\u1ec1 th\u1eddi gian s\u1ed1ng kh\u00f4ng b\u1ec7nh ti\u1ebfn tri\u1ec3n gi\u1eefa nh\u00e1nh s\u1eed d\u1ee5ng pembrolizumab so v\u1edbi nh\u00e1nh s\u1eed d\u1ee5ng cetuximab k\u1ebft h\u1ee3p v\u1edbi h\u00f3a tr\u1ecb li\u1ec7u tr\u00ean to\u00e0n b\u1ed9 qu\u1ea7n th\u1ec3 BN.<\/p>\n<p>C\u00e1c bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i ph\u1ed5 bi\u1ebfn trong th\u1eed nghi\u1ec7m KEYNOTE-48 :<\/p>\n<ul>\n<li>Tr\u00ean nh\u00f3m BN s\u1eed d\u1ee5ng pembrolizumab \u0111\u01a1n \u0111\u1ed9c : 20% BN m\u1ec7t m\u1ecfi, t\u00e1o b\u00f3n v\u00e0 n\u1ed5i ban.<\/li>\n<li>Tr\u00ean nh\u00f3m BN s\u1eed d\u1ee5ng pembrolizumab k\u1ebft h\u1ee3p v\u1edbi h\u00f3a tr\u1ecb li\u1ec7u : 20% BN n\u00f4n, bu\u1ed3n n\u00f4n, m\u1ec7t m\u1ecfi, t\u00e1o b\u00f3n, nhi\u1ec5m tr\u00f9ng ni\u00eam m\u1ea1c, vi\u00eam d\u1ea1 d\u00e0y, ti\u00eau ch\u1ea3y, ch\u00e1n \u0103n v\u00e0 ho.<\/li>\n<li>Li\u1ec1u khuy\u1ebfn c\u00e1o s\u1eed d\u1ee5ng pembrolizumab cho BN HNSCC l\u00e0 200mg \u0111\u01b0\u1eddng ti\u00eam truy\u1ec1n t\u0129nh m\u1ea1ch IV trong v\u00f2ng 30 ph\u00fat m\u1ed7i ba tu\u1ea7n, th\u1eddi gian s\u1eed d\u1ee5ng \u0111\u1ebfn khi b\u1ec7nh ti\u1ebfn tri\u1ec3n, kh\u00f4ng th\u1ec3 ch\u1ecbu \u0111\u01b0\u1ee3c \u0111\u1ed9c t\u00ednh ho\u1eb7c trong v\u00f2ng 24 th\u00e1ng v\u1edbi BN kh\u00f4ng c\u00f3 b\u1ec7nh ti\u1ebfn tri\u1ec3n.<\/li>\n<\/ul>\n<p>Ngu\u1ed3n: ESMO Link\u00a0<a href=\"https:\/\/www.esmo.org\/Oncology-News\/FDA-Approves-Pembrolizumab-for-First-line-Treatment-of-HNSCC\" rel=\"noopener\">https:\/\/www.esmo.org\/Oncology-News\/FDA-Approves-Pembrolizumab-for-First-line-Treatment-of-HNSCC<\/a><\/p>\n<p>D\u1ecbch b\u1edfi: Nguy\u1ec5n Uy\u00ean &#8211; Namud Insider.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ng\u00e0y 10\/06\/2019, c\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m M\u1ef9 (FDA) \u0111\u00e3 ph\u00ea duy\u1ec7t Pembrolizumab (KEYTRUDA, Merck &amp; Co., Inc.) trong ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb b\u01b0\u1edbc m\u1ed9t tr\u00ean BN ung th\u01b0 bi\u1ec3u m\u00f4 t\u1ebf b\u00e0o v\u1ea3y \u1edf \u0111\u1ea7u c\u1ed5 (HNSCC \u2013 Head and neck squamous cell carcinoma) giai \u0111o\u1ea1n di c\u0103n ho\u1eb7c t\u00e1i [&#8230;]\n","protected":false},"author":1,"featured_media":11707,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-11704","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-y-te-suc-khoe"],"acf":[],"_links":{"self":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/11704","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/comments?post=11704"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/11704\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/11707"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=11704"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=11704"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=11704"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}