Le 13 f\u00e9vrier 2026, la soci\u00e9t\u00e9 Pfizer Europe MA EEIG a retir\u00e9 sa demande d\u2019autorisation de mise sur le march\u00e9 aupr\u00e8s de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) pour Zumrad, un m\u00e9dicament destin\u00e9 au traitement du cancer de la vessie non infiltrant le muscle (NMIBC) \u00e0 haut risque, en association avec le Bacille de Calmette-Gu\u00e9rin (BCG) chez l\u2019adulte n\u2019ayant pas re\u00e7u de traitement pr\u00e9alable par BCG. Zumrad contient le principe actif sasanlimab, un anticorps monoclonal administr\u00e9 par voie sous-cutan\u00e9e, con\u00e7u pour bloquer le r\u00e9cepteur PD\u20111 sur les lymphocytes T et ainsi emp\u00eacher l\u2019inactivation de ces cellules par les prot\u00e9ines tumorales PD\u2011L1 et PD\u2011L2, afin de renforcer la r\u00e9ponse immunitaire contre les cellules canc\u00e9reuses.<\/p>\n
La demande d\u2019AMM s\u2019appuyait principalement sur une \u00e9tude incluant 1 055 adultes atteints de NMIBC \u00e0 haut risque, n\u2019ayant jamais re\u00e7u de BCG ou n\u2019en ayant pas re\u00e7u depuis au moins deux ans. Le sch\u00e9ma comparait l\u2019association Zumrad + BCG \u00e0 BCG seul. Zumrad \u00e9tait administr\u00e9 toutes les quatre semaines pendant une dur\u00e9e maximale de deux ans, tandis que le BCG \u00e9tait administr\u00e9 une fois par semaine pendant six semaines, puis en entretien sur cinq cycles. Le crit\u00e8re principal d\u2019efficacit\u00e9 \u00e9tait la dur\u00e9e sans \u00e9v\u00e9nement li\u00e9 \u00e0 la maladie (r\u00e9cidive ou aggravation du cancer, pr\u00e9sence de cellules tumorales dans la paroi v\u00e9sicale, d\u00e9c\u00e8s toutes causes confondues). L\u2019\u00e9tude \u00e9valuait \u00e9galement la survie globale apr\u00e8s le d\u00e9but du traitement.<\/p>\n
Au moment du retrait, l\u2019EMA avait d\u00e9j\u00e0 \u00e9valu\u00e9 des donn\u00e9es initiales, formul\u00e9 des questions \u00e0 l\u2019entreprise et \u00e9tait en cours d\u2019examen des r\u00e9ponses. Sur la base de cette analyse, l\u2019Agence exprimait des r\u00e9serves et sa position provisoire \u00e9tait que Zumrad ne pouvait pas \u00eatre autoris\u00e9 dans cette indication. Les pr\u00e9occupations de l\u2019EMA portaient notamment sur les r\u00e9sultats principaux de l\u2019\u00e9tude, en raison de modifications importantes du protocole en cours d\u2019\u00e9tude et du changement de la m\u00e9thode statistique utilis\u00e9e pour mesurer l\u2019efficacit\u00e9, jug\u00e9 de nature \u00e0 augmenter la probabilit\u00e9 de conclure \u00e0 un effet b\u00e9n\u00e9fique. L\u2019Agence mettait \u00e9galement en cause la pertinence du crit\u00e8re principal d\u2019efficacit\u00e9, celui-ci \u00e9tant \u00e9valu\u00e9 par les investigateurs eux-m\u00eames. Ces incertitudes m\u00e9thodologiques et de robustesse des r\u00e9sultats ont constitu\u00e9 un \u00e9l\u00e9ment central dans l\u2019appr\u00e9ciation du rapport b\u00e9n\u00e9fice\/risque et dans le contexte du retrait de la demande d\u2019AMM. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 13 f\u00e9vrier 2026, la soci\u00e9t\u00e9 Pfizer Europe MA EEIG a retir\u00e9 sa demande d\u2019autorisation de mise sur le march\u00e9 aupr\u00e8s de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) pour Zumrad, un […]<\/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-17729","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\/17729","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=17729"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17729\/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=17729"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17729"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17729"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}