{"id":80140,"date":"2026-05-09T08:07:08","date_gmt":"2026-05-09T08:07:08","guid":{"rendered":"https:\/\/www.europesays.com\/cz\/80140\/"},"modified":"2026-05-09T08:07:08","modified_gmt":"2026-05-09T08:07:08","slug":"prelomovy-lek-na-rakovinu-slinivky-v-usa-ziskal-povoleni-pro-prvni-pacienty","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/cz\/80140\/","title":{"rendered":"P\u0159elomov\u00fd l\u00e9k na rakovinu slinivky. V\u00a0USA z\u00edskal povolen\u00ed pro prvn\u00ed pacienty"},"content":{"rendered":"

L\u00e9k zn\u00e1m\u00fd tak\u00e9 pod ozna\u010den\u00edm RMC-6236\u00a0vyv\u00edj\u00ed biotechnologick\u00e1 spole\u010dnost Revolution Medicines. Zam\u011b\u0159uje se na mutaci genu KRAS, kter\u00e1 stoj\u00ed za r\u016fstem n\u00e1doru p\u0159ibli\u017en\u011b u\u00a0dev\u00edti z\u00a0deseti p\u0159\u00edpad\u016f rakoviny slinivky b\u0159i\u0161n\u00ed.<\/p>\n

Pr\u00e1v\u011b mutace genu KRAS byla des\u00edtky let pova\u017eov\u00e1na za prakticky nel\u00e9\u010ditelnou. Gen KRAS toti\u017e \u0159\u00edd\u00ed bun\u011b\u010dn\u00fd r\u016fst a\u00a0jeho po\u0161kozen\u00ed zp\u016fsobuje nekontrolovan\u00e9 d\u011blen\u00ed n\u00e1dorov\u00fdch bun\u011bk. V\u011bdc\u016fm se v\u0161ak poda\u0159ilo vyvinout l\u00e1tky, kter\u00e9 dok\u00e1\u017eou zmutovan\u00fd protein zablokovat a\u00a0zastavit sign\u00e1ly podporuj\u00edc\u00ed r\u016fst n\u00e1doru.<\/p>\n

Daraxonrasib pat\u0159\u00ed mezi takzvan\u00e9 inhibitory KRAS. U\u017e\u00edv\u00e1 se jednou denn\u011b ve form\u011b tablet a\u00a0podle dosavadn\u00edch v\u00fdsledk\u016f by mohl p\u0159edstavovat z\u00e1sadn\u00ed posun v\u00a0l\u00e9\u010db\u011b pacient\u016f s\u00a0metastatick\u00fdm dukt\u00e1ln\u00edm adenokarcinomem slinivky (PDAC), tedy nej\u010dast\u011bj\u0161\u00ed a\u00a0z\u00e1rove\u0148 velmi agresivn\u00ed formou tohoto onemocn\u011bn\u00ed.<\/p>\n

<\/a>Mimo\u0159\u00e1dn\u011b nad\u011bjn\u00e9<\/p>\n

V\u00fdsledky klinick\u00fdch test\u016f ozna\u010duj\u00ed onkologov\u00e9 za mimo\u0159\u00e1dn\u011b nad\u011bjn\u00e9. U\u00a0pacient\u016f, u\u00a0nich\u017e selhala standardn\u00ed chemoterapie, se poda\u0159ilo sn\u00ed\u017eit riziko \u00famrt\u00ed p\u0159ibli\u017en\u011b o\u00a060\u00a0procent. Medi\u00e1n p\u0159e\u017eit\u00ed se podle zve\u0159ejn\u011bn\u00fdch dat zv\u00fd\u0161il z\u00a06,7\u00a0na 13,2\u00a0m\u011bs\u00edce.<\/p>\n

Na prvn\u00ed pohled nemus\u00ed rozd\u00edl n\u011bkolika m\u011bs\u00edc\u016f p\u016fsobit dramaticky. U\u00a0rakoviny slinivky v\u0161ak jde podle odborn\u00edk\u016f o\u00a0v\u00fdznamn\u00fd posun. Toto onemocn\u011bn\u00ed toti\u017e pat\u0159\u00ed mezi n\u00e1dory s\u00a0nejni\u017e\u0161\u00ed m\u00edrou p\u0159e\u017eit\u00ed a\u00a0nov\u00e9 \u00fa\u010dinn\u00e9 l\u00e9ky a\u00a0l\u00e9\u010debn\u00e9 metody se doned\u00e1vna objevovaly jen velmi vz\u00e1cn\u011b.<\/p>\n

\u201eTato mo\u017enost je nepodobn\u00e1 ni\u010demu, co jsme v\u00a0l\u00e9\u010db\u011b rakoviny slinivky skute\u010dn\u011b vid\u011bli po mnoho let,\u201c uvedl pro magaz\u00edn National Geographic<\/a> onkolog Chris Chen ze Stanford University School of Medicine. Podle n\u011bj jde o \u201eskute\u010dn\u011b p\u0159evratn\u00fd okam\u017eik\u201c v\u00a0l\u00e9\u010db\u011b tohoto typu rakoviny.<\/p>\n

Na mimo\u0159\u00e1dn\u011b slibn\u00e9 v\u00fdsledky reagoval tak\u00e9 americk\u00fd \u00da\u0159ad pro kontrolu potravin a\u00a0l\u00e9\u010div (FDA). Ten na po\u010d\u00e1tku kv\u011btna schv\u00e1lil zah\u00e1jen\u00ed takzvan\u00e9ho programu roz\u0161\u00ed\u0159en\u00e9ho p\u0159\u00edstupu (Expanded Access Protocol, EAP). Protokol umo\u017e\u0148uje l\u00e9ka\u0159\u016fm pod\u00e1vat experiment\u00e1ln\u00ed l\u00e9k vybran\u00fdm pacient\u016fm je\u0161t\u011b p\u0159ed jeho definitivn\u00ed registrac\u00ed a\u00a0uveden\u00edm na trh.<\/p>\n

\u00da\u0159ad uvedl, \u017ee \u017e\u00e1dost obdr\u017eel 28.\u00a0dubna a\u00a0schv\u00e1lil ji u\u017e o\u00a0dva dny pozd\u011bji. Podle komisa\u0159e FDA Martyho Makaryho<\/a> tak rychl\u00fd postup odr\u00e1\u017e\u00ed snahu zajistit pacient\u016fm s\u00a0v\u00e1\u017en\u00fdmi a\u00a0\u017eivot ohro\u017euj\u00edc\u00edmi nemocemi co nejrychlej\u0161\u00ed p\u0159\u00edstup k\u00a0nad\u011bjn\u00fdm terapi\u00edm.<\/p>\n

Daraxonrasib u\u017e d\u0159\u00edve z\u00edskal od FDA status pr\u016flomov\u00e9 terapie. Ten je vyhrazen l\u00e9\u010div\u016fm, kter\u00e1 mohou znamenat v\u00fdrazn\u00e9 zlep\u0161en\u00ed oproti dosavadn\u00ed l\u00e9\u010db\u011b a\u00a0umo\u017e\u0148uje urychlen\u00e9 posuzov\u00e1n\u00ed.<\/p>\n

Spole\u010dnost Revolution Medicines nyn\u00ed p\u0159ipravuje \u017e\u00e1dost o\u00a0pln\u00e9 schv\u00e1len\u00ed l\u00e9ku. Do t\u00e9 doby bude daraxonrasib dostupn\u00fd pouze omezen\u00e9mu po\u010dtu pacient\u016f ve Spojen\u00fdch st\u00e1tech prost\u0159ednictv\u00edm jejich o\u0161et\u0159uj\u00edc\u00edch l\u00e9ka\u0159\u016f v\u00a0r\u00e1mci schv\u00e1len\u00e9ho programu.<\/p>\n

<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"L\u00e9k zn\u00e1m\u00fd tak\u00e9 pod ozna\u010den\u00edm RMC-6236\u00a0vyv\u00edj\u00ed biotechnologick\u00e1 spole\u010dnost Revolution Medicines. Zam\u011b\u0159uje se na mutaci genu KRAS, kter\u00e1 stoj\u00ed…\n","protected":false},"author":2,"featured_media":80141,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[17,21,2813,16,2811,25600,8880,18,19,22,25601,113,597,20],"class_list":{"0":"post-80140","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-zpravy","8":"tag-headlines","9":"tag-hlavni-udalosti","10":"tag-lecba","11":"tag-news","12":"tag-rakovina","13":"tag-rakovina-slinivky-brisni","14":"tag-slinivka","15":"tag-top-news","16":"tag-top-stories","17":"tag-udalosti-dne","18":"tag-urad-pro-kontrolu-potravin-a-leciv-fda","19":"tag-usa","20":"tag-zdravi","21":"tag-zpravy"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@cz\/116543595627487346","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/posts\/80140","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/comments?post=80140"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/posts\/80140\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/media\/80141"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/media?parent=80140"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/categories?post=80140"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/tags?post=80140"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}