Le 15 octobre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a \u00e9mis un avis positif recommandant l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9 pour le m\u00e9dicament Rasonque. Ce traitement est destin\u00e9 \u00e0 \u00eatre utilis\u00e9 en monoth\u00e9rapie chez des patients adultes atteints d\u2019ad\u00e9nocarcinome pancr\u00e9atique m\u00e9tastatique ayant re\u00e7u au moins une ligne ant\u00e9rieure de traitement syst\u00e9mique. La d\u00e9cision finale rel\u00e8ve de la Commission europ\u00e9enne, qui devra accorder l\u2019autorisation avant la publication du r\u00e9sum\u00e9 des caract\u00e9ristiques du produit (RCP) dans toutes les langues officielles de l\u2019Union europ\u00e9enne.<\/p>\n
Rasonque contient comme substance active le daraxonrasib, un agent antin\u00e9oplasique qui inhibe la famille des RAS GTPases via la formation d\u2019un complexe avec la cyclophiline A, entra\u00eenant une inhibition de la signalisation RAS et la destruction des cellules canc\u00e9reuses ou le ralentissement de leur croissance. Le code ATC n\u2019est pas encore attribu\u00e9. Le m\u00e9dicament sera disponible sous forme de comprim\u00e9s pellicul\u00e9s dos\u00e9s \u00e0 100 mg et 150 mg. Il doit \u00eatre initi\u00e9 par des m\u00e9decins exp\u00e9riment\u00e9s dans l\u2019usage des anticanc\u00e9reux. Les principaux b\u00e9n\u00e9fices mis en avant concernent une am\u00e9lioration de la survie globale m\u00e9diane (OS) et de la survie sans progression m\u00e9diane (PFS) par rapport \u00e0 une chimioth\u00e9rapie standard. Les effets ind\u00e9sirables les plus fr\u00e9quents sont des \u00e9ruptions cutan\u00e9es, des diarrh\u00e9es, des stomatites, des naus\u00e9es et des vomissements.<\/p>\n
Rasonque a b\u00e9n\u00e9fici\u00e9 du statut de m\u00e9dicament orphelin au cours de son d\u00e9veloppement, ce qui implique qu\u2019il cible une maladie rare, mena\u00e7ant le pronostic vital ou chronique et invalidante, ou pour laquelle le d\u00e9veloppement n\u2019aurait probablement pas eu lieu sans incitations \u00e9conomiques. L\u2019EMA doit encore r\u00e9examiner les donn\u00e9es disponibles pour confirmer ou non le maintien de cette d\u00e9signation orpheline. Le titulaire de la demande d\u2019autorisation est la soci\u00e9t\u00e9 Revolution Medicines Netherlands B.V., \u00e9tablie aux Pays-Bas. L\u2019identifiant de proc\u00e9dure est EMEA\/H\/C\/007122. Ces \u00e9l\u00e9ments pr\u00e9sentent un int\u00e9r\u00eat pour le suivi des innovations th\u00e9rapeutiques en oncologie et des dispositifs europ\u00e9ens relatifs aux m\u00e9dicaments orphelins, avec des implications potentielles sur l\u2019acc\u00e8s aux traitements et leur prise en charge dans les syst\u00e8mes de sant\u00e9 nationaux. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 15 octobre 2026, le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a \u00e9mis un avis positif recommandant l\u2019octroi d\u2019une autorisation de mise sur […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[257,227,226],"class_list":["post-21146","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21146","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21146"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21146\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21146"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21146"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21146"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}