{"id":100893,"date":"2025-08-22T06:46:33","date_gmt":"2025-08-22T06:46:33","guid":{"rendered":"https:\/\/www.mymsd.ch\/fr\/?post_type=product&p=100893"},"modified":"2025-08-22T06:46:52","modified_gmt":"2025-08-22T06:46:52","slug":"lignes-directrices","status":"publish","type":"product","link":"https:\/\/www.mymsd.ch\/fr\/products\/welireg\/ls005\/lignes-directrices\/","title":{"rendered":"Lignes directrices"},"content":{"rendered":"\n

WELIREG\u00ae (belzutifan) a \u00e9t\u00e9 int\u00e8gr\u00e9 dans les lignes directrices en oncologie de l’ESMO, de l’EAU et du NCCN.1,2,3<\/sup><\/h2>\n\n\n\n
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\n \n\n\n \n \n \n Lignes directrices de l’ESMO1<\/sup> <\/span>\n \n \n\n \n \n <\/use>\n<\/svg>\n <\/span>\n <\/button>\n <\/h4>\n \n
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Les directives ESMO recommandent WELIREG\u00ae dans le traitement du ccRCC avanc\u00e9 ou m\u00e9tastatique1<\/sup><\/strong><\/h4>\n\n\n
\n \"\"\n\n <\/figure>\n\n\n\n

a. ESMO-MCBS v1.1 a \u00e9t\u00e9 utilis\u00e9 pour calculer les scores des traitements\/indications approuv\u00e9s par l\u2019EMA ou la FDA. Les scores ont \u00e9t\u00e9 calcul\u00e9s et valid\u00e9s par le groupe de travail ESMO-MCBS et v\u00e9rifi\u00e9s par les auteurs (<\/em>https:\/\/www.esmo.org\/guidelines\/esmo-mcbs\/esmo-mcbs-evaluation-forms<\/em><\/a>).<\/em>
b. Non autoris\u00e9 par l\u2019EMA ou la FDA.
c. Autoris\u00e9 par la FDA, non autoris\u00e9 par l\u2019EMA.<\/em><\/p>\n\n <\/div>\n <\/div>\n<\/section>\n\n<\/div>\n\n<\/div>\n\n\n

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\n \n\n\n \n \n \n Lignes directrices de l\u2019EAU2<\/sup> <\/span>\n \n \n\n \n \n <\/use>\n<\/svg>\n <\/span>\n <\/button>\n <\/h4>\n \n
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Recommandations actualis\u00e9es des lignes directrices de l\u2019EAU pour le traitement de 1\u00e8re ligne du cc-mRCC2<\/sup><\/strong><\/h4>\n\n\n
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Recommandations des lignes directrices de l\u2019UAE pour le traitement dans les lignes suivantes2<\/sup><\/strong><\/h4>\n\n\n
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1b: bas\u00e9 sur une \u00e9tude randomis\u00e9e contr\u00f4l\u00e9e de phase III.
2a: bas\u00e9 sur une \u00e9tude bien con\u00e7ue sans randomisation ou sur une analyse de sous-groupes d\u2019une \u00e9tude randomis\u00e9e contr\u00f4l\u00e9e.
2b: analyse de sous-groupes d\u2019une \u00e9tude randomis\u00e9e contr\u00f4l\u00e9e de phase III.
* Avis d\u2019expert.<\/em><\/p>\n\n <\/div>\n <\/div>\n<\/section>\n\n<\/div>\n\n<\/div>\n\n\n

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\n \n\n\n \n \n \n Lignes directrices du NCCN3<\/sup> <\/span>\n \n \n\n \n \n <\/use>\n<\/svg>\n <\/span>\n <\/button>\n <\/h4>\n \n
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Les directives du NCCN recommandent WELIREG\u00ae comme traitement de suivi du carcinome r\u00e9nal \u00e0 cellules claires3<\/sup><\/strong><\/h4>\n\n\n\n

Fondements du traitement syst\u00e9mique au stade IV ou lors de maladie r\u00e9cidivante<\/p>\n\n\n

\n \"\"\n\n <\/figure>\n\n\n\n

b. Directives du NCCN pour la prise en charge des toxicit\u00e9s li\u00e9es \u00e0 l\u2019immunoth\u00e9rapie.
c. Nivolumab et hyaluronidase-nvhy pour injection sous-cutan\u00e9e peuvent \u00eatre remplac\u00e9s par Nivolumab IV. Les instructions de dosage et d\u2019administration du nivolumab et de l\u2019hyaluronidase nvhy diff\u00e8rent de celles du nivolumab IV (non autoris\u00e9 en Suisse).
d. Nivolumab et hyaluronidase nvhy ne sont pas autoris\u00e9s en association avec l\u2019ipilimumab IV; pour la monoth\u00e9rapie par nivolumab, le nivolumab et l\u2019hyaluronidase-nvhy pour injection souscutan\u00e9e peuvent \u00eatre remplac\u00e9s par le nivolumab IV. Le nivolumab et l\u2019hyaluronidase-nvhy sont soumis \u00e0 des instructions de dosage et d\u2019administration diff\u00e9rentes de celles du nivolumab IV (non autoris\u00e9 en Suisse).
e. Ce traitement convient aux patient:es qui ont re\u00e7u un inhibiteur de la prot\u00e9ine de la mort cellulaire programm\u00e9e de type 1 (PD-1) ou du ligand de la prot\u00e9ine de la mort cellulaire programm\u00e9e de type 1 (PD-L1) et un inhibiteur de tyrosine kinase du facteur de croissance endoth\u00e9lial vasculaire (VEGF-TKI).
f. Un biosimilaire approuv\u00e9 par la FDA est un substitut appropri\u00e9 \u00e0 toute th\u00e9rapie biologique syst\u00e9mique recommand\u00e9e dans les directives du NCCN.<\/em><\/p>\n\n <\/div>\n <\/div>\n<\/section>\n\n<\/div>\n\n<\/div>\n\n <\/div>\n\n <\/div>\n\n\n\n

<\/div>\n\n\n\n
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\n \n Des exemplaires des publications de l’\u00e9tude peuvent \u00eatre demand\u00e9s \u00e0 dpoc.switzerland@msd.com si n\u00e9cessaire.<\/span>\n <\/a><\/div>\n\n\n
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Abr\u00e9viations<\/strong><\/em><\/strong><\/em><\/strong><\/em>:<\/h6>\n\n\n\n

ccRCC<\/strong>: carcinome r\u00e9nal \u00e0 cellules claires (clear cell renal cell carcinoma); EAU<\/strong>: European Association of Urology; EMA<\/strong>: European Medicines Agency; ESMO<\/strong>: European Society for Medical Oncology; ESMO-MCBS<\/strong>: ESMO-Magnitude of Clinical Benefit Scale (\u00c9chelle d’\u00e9valuation de l’utilit\u00e9 clinique de l’ESMO); FDA<\/strong>: U.S. Food and Drug Administration; IO<\/strong>: immuno-oncologie; mRCC<\/strong>: carcinome \u00e0 cellules r\u00e9nales m\u00e9tastatique (metastatic renal cell carcinoma); NCCN<\/strong>: National Comprehensive Cancer Network; PD-1<\/strong>: prot\u00e9ine 1 de la mort cellulaire programm\u00e9e (programmed cell death protein 1); PD-L1<\/strong>: ligand 1 de mort cellulaire programm\u00e9e (Programmed death-ligand 1); TKI<\/strong>: inhibiteur de la tyrosine kinase (tyrosine kinase inhibitor); VEGF\/R<\/strong>: facteur\/r\u00e9cepteur du facteur de croissance de l’endoth\u00e9lium vasculaire (vascular endothelial growth factor\/receptor).<\/em><\/p>\n\n<\/div>\n\n <\/div>\n\n <\/div>\n\n\n

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R\u00e9f\u00e9rences<\/em><\/em>:<\/strong><\/h6>\n\n\n\n
    \n \n
  1. \n Powles T, et al. Renal cell carcinoma: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol 2024;35(8):692 \u2013 706.<\/em> <\/li>\n\n\n
  2. \n Bex A, et al. EAU Guidelines on renal cell carcinoma. European Association of Urology 2025, limited update March 2025, available at: http:\/\/www.uroweb.org\/guidelines\/<\/a>, derni\u00e8re consultation le 22.08.2025.<\/em> <\/li>\n\n\n
  3. \n NCCN National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines\u00ae) Kidney Cancer Version 1.2026 \u2013 July 24, 2025, available at: https:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/kidney.pdf<\/a>, derni\u00e8re consultation le 22.08.2025.<\/em> <\/li>\n\n<\/ol>\n\n<\/div>\n\n <\/div>\n\n <\/div>\n\n\n\n

    \u25bc Ce m\u00e9dicament fait l’objet d’une surveillance suppl\u00e9mentaire. Pour plus d\u2019informations, se r\u00e9f\u00e9rer \u00e0 l\u2019information professionnelle de WELIREG\u00ae disponible sous www.swissmedicinfo.ch<\/a>.<\/mark><\/em>

    Avant la prescription, veuillez consulter l\u2019information professionnelle compl\u00e8te publi\u00e9e sur     www.swissmedicinfo.ch<\/a>.<\/mark><\/em><\/p>\n\n\n

    \n \n Information professionnelle de WELIREG\u00ae<\/span>\n <\/a><\/div>\n\n\n
    \n \n Information professionnelle abr\u00e9g\u00e9e de WELIREG\u00ae<\/span>\n <\/a><\/div>\n","protected":false},"excerpt":{"rendered":"

    WELIREG\u00ae (belzutifan) a \u00e9t\u00e9 int\u00e8gr\u00e9 dans les lignes directrices en oncologie de l’ESMO, de l’EAU et du 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