{"id":102984,"date":"2025-08-22T06:59:44","date_gmt":"2025-08-22T06:59:44","guid":{"rendered":"https:\/\/www.mymsd.ch\/it\/?post_type=product&p=102984"},"modified":"2025-08-22T06:59:52","modified_gmt":"2025-08-22T06:59:52","slug":"linee-guida","status":"publish","type":"product","link":"https:\/\/www.mymsd.ch\/it\/products\/welireg\/ls005\/linee-guida\/","title":{"rendered":"Linee guida"},"content":{"rendered":"\n

WELIREG\u00ae (Belzutifan) \u00e8 stato inserito nelle linee guida oncologiche dell’ESMO, dell’EAU e dell’NCCN.1,2,3<\/sup><\/h2>\n\n\n\n
<\/div>\n\n\n
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\n \n\n\n \n \n \n Linee guida dell\u2019ESMO1<\/sup> <\/span>\n \n \n\n \n \n <\/use>\n<\/svg>\n <\/span>\n <\/button>\n <\/h4>\n \n
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Le linee guida dell’ESMO raccomandano WELIREG\u00ae nel trattamento del ccRCC avanzato o metastatico1<\/sup><\/strong><\/h4>\n\n\n
\n \"\"\n\n <\/figure>\n\n\n\n

a. a. L’ESMO-MCBS v1.1 \u00e8 stato utilizzato per calcolare i punteggi relativi alle terapie\/indicazioni approvate dall’EMA o dalla FDA. I punteggi sono stati calcolati e convalidati dal gruppo di lavoro ESMO-MCBS e verificati dagli autori (<\/em>https:\/\/www.esmo.org\/guidelines\/esmo-mcbs\/esmo-mcbs-evaluation-forms<\/em><\/a>).<\/em>
b. Non omologato dall’EMA o dalla FDA.
c. Omologato dalla FDA, non omologato dall’EMA.<\/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 Linee guida dell\u2019EAU2<\/sup> <\/span>\n \n \n\n \n \n <\/use>\n<\/svg>\n <\/span>\n <\/button>\n <\/h4>\n \n
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Raccomandazioni aggiornate delle linee guida dell’EAU per il trattamento di prima linea del cc-mRCC2<\/sup><\/strong><\/h4>\n\n\n
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Raccomandazioni delle linee guida dell’EAU per la terapia in linee successive2<\/sup><\/strong><\/h4>\n\n\n
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1b: basato su uno studio randomizzato controllato di fase III.
2a: basato su uno studio ben progettato senza randomizzazione o su un’analisi di sottogruppi di uno studio randomizzato controllato.
2b: analisi di sottogruppi di uno studio randomizzato controllato di fase III.
* Opinione degli esperti.<\/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 Linee guida dell\u2019NCCN3<\/sup> <\/span>\n \n \n\n \n \n <\/use>\n<\/svg>\n <\/span>\n <\/button>\n <\/h4>\n \n
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Le linee guida dell’NCCN raccomandano WELIREG\u00ae come terapia di follow-up nel carcinoma renale a cellule chiare3<\/sup><\/strong><\/h4>\n\n\n\n

Fondamenti della terapia sistemica nella fase IV o nella malattia recidivante<\/p>\n\n\n

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

b. Linee guida dell’NCCN per la gestione delle tossicit\u00e0 correlate all’immunoterapia.
c. Nivolumab e ialuronidasi-nvhy per iniezione sottocutanea possono essere sostituiti con nivolumab per via endovenosa. Per nivolumab e ialuronidasi-nvhy valgono istruzioni di dosaggio e somministrazione diverse rispetto a quelle per nivolumab per via endovenosa (non autorizzato in Svizzera).
d. Nivolumab e ialuronidasi-nvhy non sono approvati per l’uso concomitante con ipilimumab per via endovenosa; per la monoterapia con nivolumab, nivolumab e ialuronidasi-nvhy per iniezione sottocutanea possono essere sostituiti con nivolumab per via endovenosa. Per nivolumab e ialuronidasi-nvhy valgono indicazioni relative al dosaggio e alla somministrazione diverse da quelle relative al nivolumab per via endovenosa (non autorizzato in Svizzera)
e. Questa terapia \u00e8 indicata per pazienti che hanno ricevuto un inibitore della proteina 1 della morte cellulare programmata (PD-1) o del ligando 1 della morte programmata (PD-L1) e un inibitore della tirosin-chinasi del fattore di crescita endoteliale vascolare (VEGF-TKI).
f. Un biosimilare approvato dalla FDA \u00e8 un sostituto adeguato per qualsiasi terapia biologica sistemica raccomandata dalle linee guida dell’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 All’occorrenza, \u00e8 possibile richiedere copie delle pubblicazioni degli studi all’indirizzo dpoc.switzerland@msd.com.<\/span>\n <\/a><\/div>\n\n\n\n
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Abbreviazioni<\/strong>:<\/mark><\/em><\/h6>\n\n\n\n

ccRCC<\/strong>: carcinoma renale a cellule chiare (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 (Scala per valutare l’entit\u00e0 del beneficio clinico dell’ESMO); FDA<\/strong>: U.S. Food and Drug Administration; IO<\/strong>: immuno-oncologia; mRCC<\/strong>: carcinoma a cellule renali metastatico (metastatic renal cell carcinoma); NCCN<\/strong>: National Comprehensive Cancer Network; PD-1<\/strong>: proteina 1 della morte cellulare programmata (programmed cell death protein 1); PD-L1<\/strong>: ligando 1 della morte cellulare programmata (Programmed death-ligand 1); TKI<\/strong>: inibitore delle tirosin-chinasi (tyrosine kinase inhibitor); VEGF\/R<\/strong>: fattore di crescita\/recettore del fattore di crescita dell’endotelio vascolare (vascular endothelial growth factor\/receptor).<\/em><\/p>\n\n<\/div>\n\n <\/div>\n\n <\/div>\n\n\n

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Riferimenti bibliografici:<\/strong> <\/mark><\/em><\/h6>\n\n\n\n

<\/p>\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>, ultima consultazione il 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>, ultima consultazione il 22.08.2025.<\/em> <\/li>\n\n<\/ol>\n\n<\/div>\n\n <\/div>\n\n <\/div>\n\n\n\n

    \u25bc Questo medicamento \u00e8 soggetto a monitoraggio addizionale. Per ulteriori informazioni, vedere l\u2019informazione professionale di WELIREG\u00ae su www.swissmedicinfo.ch<\/a>.<\/mark><\/em>

    Prima della prescrizione, consultare l\u2019informazione professionale completa pubblicata sul sito      www.swissmedicinfo.ch<\/a>.<\/mark><\/em><\/p>\n\n\n

    \n \n Informazione professionale di WELIREG\u00ae<\/span>\n <\/a><\/div>\n\n\n
    \n \n Informazione professionale breve di WELIREG\u00ae<\/span>\n <\/a><\/div>\n","protected":false},"excerpt":{"rendered":"

    WELIREG\u00ae (Belzutifan) \u00e8 stato inserito nelle linee guida oncologiche dell’ESMO, dell’EAU e 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