{"id":1856,"date":"2023-04-28T17:20:00","date_gmt":"2023-04-28T15:20:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1856"},"modified":"2024-03-30T17:23:37","modified_gmt":"2024-03-30T16:23:37","slug":"28-liecivo-pembrolizumab-keytruda-v-monoterapii-alebo-v-kombinacii-s-chemoterapiou-obsahujucou-platinu-a-5-fluoruracil-v-prvej-linii-metastatickeho-alebo-neresekovatelneho-rekurentneho-skvamocelula","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/28-liecivo-pembrolizumab-keytruda-v-monoterapii-alebo-v-kombinacii-s-chemoterapiou-obsahujucou-platinu-a-5-fluoruracil-v-prvej-linii-metastatickeho-alebo-neresekovatelneho-rekurentneho-skvamocelula\/","title":{"rendered":"28: Lie\u010divo pembrolizumab (Keytruda) v monoterapii alebo v kombin\u00e1cii s chemoterapiou obsahuj\u00facou platinu a 5-flu\u00f3ruracil v prvej l\u00ednii metastatick\u00e9ho alebo neresekovate\u013en\u00e9ho rekurentn\u00e9ho skvamocelul\u00e1rneho karcin\u00f3mu hlavy a krku u dospely\u0301ch"},"content":{"rendered":"
    \n
  1. Ak\u00e1 je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako z\u00e1sadn\u00e9 je ochorenie?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Skvamocelul\u00e1rny karcin\u00f3m hlavy a krku (HNSCC) sa vytv\u00e1ra z buniek dla\u017edicov\u00e9ho epitelu na povrchu horn\u00e9ho a doln\u00e9ho d\u00fdchacieho traktu (pery, jazyk, \u00fastna dutina, hltan, hrtan, hlasivky), alebo v nose a pr\u00ednosov\u00fdch dutin\u00e1ch. Z povahy umiestnenia karcin\u00f3mu na hlave a krku je ochorenie pre pacientov ve\u013emi stigmatizuj\u00face. V\u00fdsledok chirurgick\u00e9ho odstr\u00e1nenia nemus\u00ed by\u0165 pre pacienta prijate\u013en\u00fd z funk\u010dn\u00e9ho \u010di estetick\u00e9ho h\u013eadiska. Klinick\u00ed odborn\u00edci na Slovensku by ocenili mo\u017enos\u0165 modernej lie\u010dby pod\u013ea medzin\u00e1rodn\u00fdch \u0161tandardov, vr\u00e1tane mo\u017enosti pou\u017ei\u0165 lie\u010divo v monoterapii, bez nutnosti pod\u00e1vania chemoterapie.<\/p>\n\n\n\n

      \n
    1. O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n

      KEYTRUDA obsahuje lie\u010divo pembrolizumab, ktor\u00fd je monoklon\u00e1lna protil\u00e1tka. KEYTRUDA \u00fa\u010dinkuje tak, \u017ee pom\u00e1ha v\u00e1\u0161mu imunitn\u00e9mu syst\u00e9mu bojova\u0165 proti rakovine.<\/p>\n\n\n\n

      Liek Keytruda bol prv\u00fdkr\u00e1t registrovan\u00fd v EMA (Eur\u00f3pska liekov\u00e1 agent\u00fara) v 07\/2015 pod \u010d\u00edslom EMEA\/H\/C\/003820 a postupne mu bola roz\u0161\u00edren\u00e1 indik\u00e1cia na viacero druhov rakoviny najm\u00e4 u dospel\u00fdch v monoterapii alebo ako adjuvantn\u00e1 lie\u010dba.<\/p>\n\n\n\n

      Pre pou\u017eitie lieku v hodnotenej indik\u00e1cii bola Keytruda schv\u00e1len\u00e1 v okt\u00f3bri 2019.<\/p>\n\n\n\n

        \n
      1. Ako sa na axikabtag\u00e9n ciloleucel pozeraj\u00fa odborn\u00edci? <\/strong><\/li>\n<\/ol>\n\n\n\n

        Klinick\u00fd odborn\u00edk pouk\u00e1zal na probl\u00e9m ch\u00fdbaj\u00facich lie\u010div v\u0161eobecne aj v predmetnej indik\u00e1cii. Kategoriz\u00e1cia lieku Keytruda v predmetnej indik\u00e1cii by preto bola onkol\u00f3gmi, ktor\u00ed lie\u010dia t\u00fato diagn\u00f3zu, v\u00edtan\u00e1. Tie\u017e sa vyjadril, \u017ee lie\u010dba imunoterapiou je \u0161tandardom terapie v predmetnej indik\u00e1cii pod\u013ea ESMO (European Society for Medical Oncology \u2013 Eur\u00f3pska spolo\u010dnos\u0165 pre medic\u00ednsku onkol\u00f3giu) aj NCCN (National Comprehensive Cancer Network \u2013 N\u00e1rodn\u00e1 (americk\u00e1) sie\u0165 zdru\u017euj\u00faca najd\u00f4le\u017eitej\u0161ie onkologick\u00e9 pracovisk\u00e1). To znamen\u00e1, \u017ee pacienti nemaj\u00fa aktu\u00e1lne be\u017ene hraden\u00fa lie\u010dbu pod\u013ea najnov\u0161\u00edch medzin\u00e1rodn\u00fdch odpor\u00fa\u010dan\u00ed.<\/p>\n\n\n\n

          \n
        1. \u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ol>\n\n\n\n

          Dr\u017eite\u013e registr\u00e1cie (Merck Sharp & Dohme B.V. (NLD)) podal \u017eiados\u0165 o zaradenie lie\u010diva pembrolizumab (Keytruda) v monoterapii alebo v kombin\u00e1cii s chemoterapiou obsahuj\u00facou platinu a 5-flu\u00f3ruracil v prvej l\u00ednii metastatick\u00e9ho alebo neresekovate\u013en\u00e9ho rekurentn\u00e9ho skvamocelul\u00e1rneho karcin\u00f3mu hlavy a krku u dospel\u00fdch<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku keytruda v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby sp\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/p>\n\n\n\n

          Okrem toho NIHO odpor\u00fa\u010da zv\u00e1\u017ei\u0165 doplnenie indika\u010dn\u00e9ho obmedzenia pod\u013ea n\u00e1vrhu NIHO.<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku keytruda v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby sp\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti…<\/p>","protected":false},"author":3,"featured_media":1857,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[92,93],"class_list":["post-1856","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-keytruda","tag-pembrolizumab"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1856","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1856"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1856\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1857"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1856"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1856"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1856"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}