Le 28 ao\u00fbt 2026, la Commission europ\u00e9enne a retir\u00e9 l\u2019autorisation de mise sur le march\u00e9 (AMM) de Pemetrexed medac (p\u00e9m\u00e9trexed) dans l\u2019Union europ\u00e9enne. Ce retrait intervient \u00e0 la demande du titulaire de l\u2019AMM, l\u2019entreprise allemande medac Gesellschaft f\u00fcr klinische Spezialpr\u00e4parate mbH, qui a inform\u00e9 la Commission de sa d\u00e9cision d\u2019arr\u00eater d\u00e9finitivement la commercialisation du produit pour des raisons commerciales. Le m\u00e9dicament n\u2019\u00e9tait plus commercialis\u00e9 dans l\u2019UE depuis le 3 juin 2026.<\/p>\n
Pemetrexed medac est un m\u00e9dicament g\u00e9n\u00e9rique d\u2019Alimta. D\u2019autres m\u00e9dicaments g\u00e9n\u00e9riques d\u2019Alimta restent autoris\u00e9s et commercialis\u00e9s dans l\u2019UE, ce qui limite l\u2019impact potentiel de ce retrait sur l\u2019acc\u00e8s au traitement pour les patients.<\/p>\n
L\u2019AMM europ\u00e9enne de Pemetrexed medac avait \u00e9t\u00e9 accord\u00e9e le 27 novembre 2015, \u00e0 l\u2019issue d\u2019une proc\u00e9dure centralis\u00e9e impliquant le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA). Initialement valable 5 ans, elle avait \u00e9t\u00e9 prolong\u00e9e \u00e0 dur\u00e9e illimit\u00e9e en 2020. La derni\u00e8re proc\u00e9dure ayant modifi\u00e9 les informations sur le produit (r\u00e9f\u00e9rence VR\/00002617) date du 28 mai 2025.<\/p>\n
Pemetrexed medac appartenait au groupe pharmacoth\u00e9rapeutique des analogues de l\u2019acide folique (antin\u00e9oplasiques, code ATC L01BA04) et \u00e9tait indiqu\u00e9 dans le traitement des cancers suivants : m\u00e9soth\u00e9liome pleural malin et cancer bronchique non \u00e0 petites cellules (CBNPC) autre qu\u2019\u00e0 pr\u00e9dominance \u00e9pidermo\u00efde. En association au cisplatine, il \u00e9tait indiqu\u00e9 en premi\u00e8re ligne chez les patients chimiona\u00effs atteints de m\u00e9soth\u00e9liome pleural malin non r\u00e9s\u00e9cable, ainsi qu\u2019en premi\u00e8re ligne chez les patients atteints de CBNPC localement avanc\u00e9 ou m\u00e9tastatique ne pr\u00e9sentant pas de pr\u00e9dominance histologique \u00e9pidermo\u00efde. En monoth\u00e9rapie, il \u00e9tait indiqu\u00e9 en traitement d\u2019entretien du CBNPC localement avanc\u00e9 ou m\u00e9tastatique, autre qu\u2019\u00e0 pr\u00e9dominance \u00e9pidermo\u00efde, chez les patients dont la maladie ne progressait pas imm\u00e9diatement apr\u00e8s une chimioth\u00e9rapie \u00e0 base de platine, et en traitement de deuxi\u00e8me ligne dans les m\u00eames conditions histologiques.<\/p>\n
Les principales autorit\u00e9s et acteurs concern\u00e9s sont la Commission europ\u00e9enne, qui a formellement retir\u00e9 l\u2019AMM, l\u2019EMA et son Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP), qui avaient examin\u00e9 le dossier en 2015, ainsi que medac Gesellschaft f\u00fcr klinische Spezialpr\u00e4parate mbH, titulaire de l\u2019AMM et responsable de la d\u00e9cision d\u2019arr\u00eat commercial. L\u2019information est d\u2019int\u00e9r\u00eat pour le suivi des disponibilit\u00e9s en oncologie, dans un contexte o\u00f9 la continuit\u00e9 d\u2019acc\u00e8s repose sur la pr\u00e9sence d\u2019autres g\u00e9n\u00e9riques de la m\u00eame sp\u00e9cialit\u00e9 de r\u00e9f\u00e9rence. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 28 ao\u00fbt 2026, la Commission europ\u00e9enne a retir\u00e9 l\u2019autorisation de mise sur le march\u00e9 (AMM) de Pemetrexed medac (p\u00e9m\u00e9trexed) dans l\u2019Union europ\u00e9enne. Ce retrait intervient \u00e0 la demande du […]<\/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-22274","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\/22274","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=22274"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/22274\/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=22274"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=22274"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=22274"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}