Le document pr\u00e9sente l\u2019\u00e9valuation europ\u00e9enne du m\u00e9dicament Mepact par le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), qui a abouti \u00e0 un avis favorable \u00e0 l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9, assortie de recommandations d\u2019utilisation.<\/p>\n
Mepact est un m\u00e9dicament hospitalier contenant du mifamurtide, pr\u00e9sent\u00e9 sous forme de poudre pour suspension pour perfusion intraveineuse. Il est indiqu\u00e9 dans le traitement de l\u2019ost\u00e9osarcome de haut grade non m\u00e9tastatique (cancer des os \u00e0 un stade pr\u00e9coce, sans extension \u00e0 distance) chez des patients \u00e2g\u00e9s de 2 \u00e0 30 ans. Il est utilis\u00e9 en association avec d\u2019autres m\u00e9dicaments anticanc\u00e9reux, apr\u00e8s chirurgie d\u2019ex\u00e9r\u00e8se de la tumeur. Le traitement doit \u00eatre initi\u00e9 et supervis\u00e9 par un m\u00e9decin sp\u00e9cialiste exp\u00e9riment\u00e9 dans le diagnostic et le traitement de l\u2019ost\u00e9osarcome. Le m\u00e9dicament est soumis \u00e0 prescription m\u00e9dicale obligatoire.<\/p>\n
En raison du faible nombre de patients concern\u00e9s, l\u2019ost\u00e9osarcome est consid\u00e9r\u00e9 comme une maladie rare. Mepact a \u00e9t\u00e9 d\u00e9sign\u00e9 m\u00e9dicament orphelin le 21 juin 2004, dans le cadre du dispositif europ\u00e9en visant les maladies rares. La posologie est adapt\u00e9e \u00e0 la taille et au poids du patient : deux administrations par semaine pendant 12 semaines, puis une administration par semaine pendant 24 semaines. Le produit est administr\u00e9 en perfusion lente d\u2019une dur\u00e9e d\u2019une heure et ne doit pas \u00eatre inject\u00e9 en bolus.<\/p>\n
Le mifamurtide est un immunomodulateur qui agit en activant certains globules blancs (macrophages et monocytes). Le m\u00e9canisme d\u2019action pr\u00e9cis dans l\u2019ost\u00e9osarcome n\u2019est pas enti\u00e8rement \u00e9lucid\u00e9, mais il est suppos\u00e9 induire la lib\u00e9ration de substances capables de d\u00e9truire les cellules canc\u00e9reuses.<\/p>\n
L\u2019efficacit\u00e9 de Mepact a \u00e9t\u00e9 \u00e9valu\u00e9e dans une \u00e9tude principale incluant 678 patients \u00e2g\u00e9s de 1 \u00e0 31 ans atteints d\u2019ost\u00e9osarcome de haut grade non m\u00e9tastatique. Apr\u00e8s la chirurgie, tous les patients ont re\u00e7u des combinaisons de m\u00e9dicaments anticanc\u00e9reux, et la moiti\u00e9 d\u2019entre eux ont en plus re\u00e7u Mepact. Le crit\u00e8re principal \u00e9tait la survie sans rechute, avec un suivi pouvant aller jusqu\u2019\u00e0 10 ans. Les r\u00e9sultats montrent qu\u2019en association aux autres anticanc\u00e9reux, Mepact augmente la proportion de patients survivant sans r\u00e9cidive : 68 % (231\/338) dans le groupe Mepact contre 61 % (207\/340) dans le groupe sans Mepact. Le risque de d\u00e9c\u00e8s a \u00e9t\u00e9 r\u00e9duit de 28 % chez les patients trait\u00e9s par Mepact.<\/p>\n
Les effets ind\u00e9sirables les plus fr\u00e9quents (plus d\u2019un patient sur dix) incluent une an\u00e9mie (diminution des globules rouges), une perte d\u2019app\u00e9tit, des c\u00e9phal\u00e9es, des \u00e9tourdissements, une tachycardie (acc\u00e9l\u00e9ration du rythme cardiaque), une hypertension ou une hypotension art\u00e9rielle, ainsi qu\u2019une dyspn\u00e9e (difficult\u00e9s respiratoires). Ces \u00e9l\u00e9ments sont importants pour la surveillance de la tol\u00e9rance et l\u2019organisation des soins.<\/p>\n
Du point de vue des politiques de sant\u00e9, ce cas illustre la mise en \u0153uvre du cadre europ\u00e9en sur les m\u00e9dicaments orphelins, le r\u00f4le central de l\u2019EMA et de son CHMP dans l\u2019\u00e9valuation des m\u00e9dicaments pour maladies rares, ainsi que l\u2019existence d\u2019options th\u00e9rapeutiques sp\u00e9cifiques pour des cancers p\u00e9diatriques et de l\u2019adulte jeune. Les donn\u00e9es chiffr\u00e9es sur la survie et le profil de s\u00e9curit\u00e9 sont susceptibles d\u2019int\u00e9resser les autorit\u00e9s sanitaires pour le suivi de l\u2019usage, l\u2019\u00e9valuation m\u00e9dico-\u00e9conomique et la planification de l\u2019offre de soins en oncologie rare. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document pr\u00e9sente l\u2019\u00e9valuation europ\u00e9enne du m\u00e9dicament Mepact par le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), qui a abouti \u00e0 un avis favorable […]<\/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-17724","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\/17724","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=17724"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17724\/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=17724"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17724"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17724"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}