{"id":1852,"date":"2023-05-12T16:47:00","date_gmt":"2023-05-12T14:47:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1852"},"modified":"2024-03-30T16:51:10","modified_gmt":"2024-03-30T15:51:10","slug":"27-liecivo-polatuzumab-vedotin-polivy-v-kombinacii-s-rituximabom-cyklofosfamidom-doxorubicinom-a-prednizonom-r-chp-na-liecbu-dospelych-pacientov-s-predtym-neliecenym-difuznym","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/27-liecivo-polatuzumab-vedotin-polivy-v-kombinacii-s-rituximabom-cyklofosfamidom-doxorubicinom-a-prednizonom-r-chp-na-liecbu-dospelych-pacientov-s-predtym-neliecenym-difuznym\/","title":{"rendered":"27: Lie\u010divo polatuzumab vedot\u00edn (Polivy) v kombin\u00e1cii s rituximabom, cyklofosfamidom, doxorubic\u00ednom a predniz\u00f3nom (R-CHP) na lie\u010dbu dospely\u0301ch pacientov s predty\u0301m nelie\u010deny\u0301m dif\u00faznym ve\u013ekobunkovy\u0301m lymf\u00f3mom z B-buniek (DLBCL)"},"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

    DLBCL vznik\u00e1 nekontrolovan\u00fdm mno\u017een\u00edm stredne ve\u013ek\u00fdch a\u017e ve\u013ek\u00fdch B-lymfocytov. Je naj\u010dastej\u0161ie sa vyskytuj\u00facim typom non-Hodgkinov\u00fdch lymf\u00f3mov (NHL) (tvor\u00ed pribli\u017ene 1\/3 pr\u00edpadov). Z\u00e1kladn\u00fdm klinick\u00fdm prejavom DLBCL je r\u00fdchlo rast\u00faca n\u00e1dorov\u00e1 masa, ktor\u00e1 m\u00f4\u017ee vznikn\u00fa\u0165 v r\u00f4znych org\u00e1noch, alebo tkaniv\u00e1ch. Pr\u00edznaky zodpovedaj\u00fa postihnut\u00fdm org\u00e1nom\/tkaniv\u00e1m. Cie\u013eom terapie je dosiahnutie \u00fapln\u00e9ho vylie\u010denia. Pacienti s DLBCL u ktor\u00fdch ochorenie za 24 mesiacov od ukon\u010denia 1. l\u00ednie lie\u010dby nesprogredovalo sa pova\u017euj\u00fa za vylie\u010den\u00fdch, pre\u017e\u00edvaj\u00fa podobne dlho ako popul\u00e1cia bez ochorenia. Aktu\u00e1lne hraden\u00e1 lie\u010dba DLBCL zodpoved\u00e1 medzin\u00e1rodn\u00fdm odpor\u00fa\u010daniam ESMO \u2013 na Slovensku sa pou\u017e\u00edva \u0161tandardn\u00e1 chemoimunoterapeutick\u00e1 lie\u010dba \u2013 terapia R-CHOP (kombin\u00e1cia rituximabu, cyklofosfamidu, doxorubic\u00ednu, vinkrist\u00ednu a predniz\u00f3nu).<\/p>\n\n\n\n

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

      Polivy je liek proti rakovine, ktor\u00fd obsahuje lie\u010divo polatuzumab vedot\u00edn. <\/p>\n\n\n\n

      Toto lie\u010divo je zlo\u017een\u00e9 z monoklon\u00e1lnej protil\u00e1tky spojenej z MMAE, \u010do je l\u00e1tka, ktor\u00e1 usmrcuje rakovinov\u00e9 bunky. \u010cas\u0165 lieku tvoren\u00e1 monoklon\u00e1lnou protil\u00e1tkou sa navia\u017ee na cie\u013eov\u00e9 B-bunky. Po naviazan\u00ed sa na B-bunky sa z lieku do B-bunky uvo\u013e\u0148uje MMAE a usmrcuje ich.<\/p>\n\n\n\n

      Tento liek bol pre predmetn\u00fa indik\u00e1ciu registrovan\u00fd v EMA v marci 2022.<\/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 na z\u00e1klade v\u00fdsledkov \u0161t\u00fadie POLARIX vid\u00ed v\u00fdznamn\u00fd klinick\u00fd pr\u00ednos hodnoten\u00e9ho lie\u010diva v porovnan\u00ed so s\u00fa\u010dasn\u00fdm lie\u010debn\u00fdm postupom a pri dlh\u0161om medi\u00e1ne sledovania nevylu\u010duje ani zlep\u0161enie v celkov\u00e9ho pre\u017e\u00edvania.<\/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 (Roche Registration GmbH) podal \u017eiados\u0165 o zaradenie lie\u010diva polatuzumab vedot\u00edn (Polivy) v kombin\u00e1cii s rituximabom, cyklofosfamidom, doxorubic\u00ednom a predniz\u00f3nom (R-CHP) na lie\u010dbu dospel\u00fdch pacientov s predt\u00fdm nelie\u010den\u00fdm dif\u00faznym ve\u013ekobunkov\u00fdm lymf\u00f3mom z B-buniek (DLBCL).<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Polivy v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie: <\/p>\n\n\n\n

            \n
          • uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby sp\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti a <\/li>\n\n\n\n
          • z\u00e1rove\u0148 z d\u00f4vodu vysokej miery neistoty, \u017ee krit\u00e9ria n\u00e1kladovej efekt\u00edvnosti v klinickej praxi nebud\u00fa splnen\u00e9, poskytne dodato\u010dn\u00fa z\u013eavu.<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"

            NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Polivy v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie…<\/p>","protected":false},"author":3,"featured_media":1853,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[91,90],"class_list":["post-1852","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-polatuzumab-vedotin","tag-polivy"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1852","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=1852"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1852\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1853"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1852"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1852"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1852"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}