Avis favorable au remboursement dans l’indication « IMFINZI, en association avec la gemcitabine et le cisplatine pour le traitement de première ligne des patients adultes atteints d’un cancer des voies biliaires (CVB) non résécable ou métastatique ».
Quel progrès ?
Un progrès thérapeutique par rapport à la chimiothérapie gemcitabine + cisplatine.
Quelle place dans la stratégie thérapeutique ?
Dans le traitement du cancer des voies biliaires (CVB) non résécable ou métastatique, IMFINZI (durvaluab), en association avec la gemcitabine et le cisplatine, est un traitement de 1ère ligne.
Clinical Benefit
Substantial
The clinical benefit of IMFINZI (durvalumab) 50 mg/mL concentrate for solution for infusion is substantial in the MA indication.
Clinical Added Value
minor
Considering:
demonstration of the superiority of durvalumab combined with gemcitabine and cisplatin compared to the gemcitabine and cisplatin combination alone, in a randomised, double-blind study, in terms of overall survival (OS, primary endpoint) and progression-free survival (PFS, ranked secondary endpoint),
the effect size deemed to be modest but significant, with an absolute difference for median OS of 1.3 months, with an HR= 0.80; CI97% [0.64; 0.99]),
the lack of formal conclusions that can be drawn from the exploratory results of the secondary endpoints, including quality of life,
a safety profile deemed to be acceptable,
the medical need partially met by the available alternatives and the evolution of guidelines for the management of advanced biliary tract cancer,
the Committee deems that IMFINZI (durvalumab) 50 mg/mL concentrate for solution for infusion provides a minor clinical added value (CAV IV) compared to gemcitabine + cisplatin chemotherapy in the first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC).
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