Le comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a recommand\u00e9 l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9 dans l\u2019Union europ\u00e9enne pour Rasonque (daraxonrasib). Ce traitement oral est destin\u00e9 aux adultes atteints d\u2019ad\u00e9nocarcinome pancr\u00e9atique m\u00e9tastatique ayant d\u00e9j\u00e0 re\u00e7u au moins une ligne de traitement pr\u00e9alable. L\u2019EMA souligne que, pour ces patients dont la maladie s\u2019est aggrav\u00e9e apr\u00e8s un traitement ant\u00e9rieur, les options th\u00e9rapeutiques sont limit\u00e9es et le pronostic d\u00e9favorable, en raison de l\u2019efficacit\u00e9 restreinte et de la toxicit\u00e9 importante des chimioth\u00e9rapies standards.<\/p>\n
Rasonque a \u00e9t\u00e9 identifi\u00e9 dans le cadre du projet \u00ab Cancer Medicines Pathfinder \u00bb de l\u2019EMA comme un m\u00e9dicament prioritaire susceptible de r\u00e9pondre \u00e0 un besoin m\u00e9dical non couvert. \u00c0 ce titre, il a fait l\u2019objet d\u2019une \u00ab phased review \u00bb (\u00e9valuation par phases), permettant au CHMP de commencer l\u2019examen plusieurs mois avant la soumission compl\u00e8te du dossier. L\u2019\u00e9valuation, commenc\u00e9e d\u00e9but juillet 2026, a port\u00e9 sur les donn\u00e9es de qualit\u00e9, non cliniques et cliniques au fur et \u00e0 mesure de leur soumission par l\u2019entreprise. Cette proc\u00e9dure a permis de r\u00e9duire le temps d\u2019\u00e9valuation active \u00e0 moins de 150 jours, tout en maintenant les exigences habituelles de qualit\u00e9, de s\u00e9curit\u00e9 et d\u2019efficacit\u00e9, contre jusqu\u2019\u00e0 210 jours dans une proc\u00e9dure standard, qui s\u2019\u00e9tend en pratique souvent sur environ un an.<\/p>\n
Selon l\u2019EMA, les enseignements tir\u00e9s de cette \u00e9valuation par phases contribueront \u00e0 la mise en \u0153uvre et au renforcement de ce type de proc\u00e9dure dans le cadre de la nouvelle l\u00e9gislation pharmaceutique de l\u2019UE. La \u00ab phased review \u00bb est envisag\u00e9e comme un outil permettant une \u00e9valuation plus agile et rationalis\u00e9e des m\u00e9dicaments, afin de favoriser un acc\u00e8s plus pr\u00e9coce des patients \u00e0 des traitements prometteurs.<\/p>\n
Sur le plan pharmacologique, le daraxonrasib est un inhibiteur de la voie RAS. Dans l\u2019ad\u00e9nocarcinome pancr\u00e9atique, des mutations du g\u00e8ne RAS conduisent \u00e0 une activation permanente des prot\u00e9ines RAS, impliqu\u00e9es dans la croissance et la survie cellulaires, entra\u00eenant une prolif\u00e9ration incontr\u00f4l\u00e9e des cellules canc\u00e9reuses. Le daraxonrasib se lie \u00e0 la cyclophiline A pour former un complexe qui se fixe sur les prot\u00e9ines RAS et bloque leur activit\u00e9, ce qui entra\u00eene la mort des cellules tumorales et ralentit la progression du cancer.<\/p>\n
L\u2019efficacit\u00e9 de Rasonque a \u00e9t\u00e9 \u00e9tudi\u00e9e dans un essai clinique de phase 3, ouvert, multinational, incluant 500 patients atteints d\u2019ad\u00e9nocarcinome pancr\u00e9atique m\u00e9tastatique dont la maladie avait progress\u00e9 apr\u00e8s un traitement syst\u00e9mique. Parmi eux, 92 % pr\u00e9sentaient une mutation RAS G12 confirm\u00e9e, incluant les mutations les plus fr\u00e9quentes dans cette pathologie. Les patients trait\u00e9s par Rasonque ont pr\u00e9sent\u00e9 une survie globale m\u00e9diane de 12,4 mois, contre 6,7 mois pour ceux trait\u00e9s par chimioth\u00e9rapie, et une survie m\u00e9diane sans progression de 7,2 mois, contre 3,6 mois sous chimioth\u00e9rapie. Les effets ind\u00e9sirables les plus fr\u00e9quents rapport\u00e9s avec Rasonque incluent la diarrh\u00e9e (informations partielles dans la source). (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a recommand\u00e9 l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9 dans l\u2019Union europ\u00e9enne pour Rasonque (daraxonrasib). 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