AIFA Agenzia Italiana del Farmaco
Web activation and publication of monitoring cards — First-line Opdivo Registry (Adenocarcinoma of the stomach, junction and esophagus)
Users of the Drug Registries subject to Monitoring are informed that, following the publication of the AIFA Determine in the OJ no. 256 of , starting from it is possible to use, under NHS reimbursement, the medicinal product OPDIVO (nivolumab) for the following therapeutic indication:
OPDIVO in combination chemotherapy based on fluoropyrimidine and platinum is indicated for the first-line treatment of adult patients with adenocarcinoma of the stomach, gastro-esophageal junction or oesophagus, HER2 negative, advanced or metastatic, whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.
Please note that the prescriptions relating only to the indication reimbursed by the National Health Service, through the aforementioned publication, must be carried out in accordance with the criteria of eligibility and prescriptive appropriateness reported in the clinical card, downloadable from the list of «Active Registers and PT», accessible from the «Related Links» box.
It is specified that, starting from , the register in question is available on the web platform (pathology «ADENOCARCINOMA OF THE STOMACH, JUNCTION AND ESOPHAGUS»); therefore the regional referents are invited to proceed with the authorization of authorized health centers, accessing the system.
It should also be noted that the OPDIVO register for the indication «Treatment in monotherapy of adult patients with squamous histotype cancer, advanced unresectable, recurrent or metastatic after previous combination chemotherapy based on fluoropyrimidine and platinum», in monitoring since , from today is available on the web platform by selecting the pathology «SQUAMOUS CARCINOMA OF THE ESOPHAGUS» (previously called «CARCINOMA OF THE ESOPHAGUS»), The new name of pathology will also be applied to treatments already started.
Monitoring Registers Office
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Source — https://www.univadis.it/viewarticle/attivazione-web-e-pubblicazione-schede-di-monitoraggio-registro-opdivo-prima-linea-adenocarcinoma-dello-stomaco-giunzione-ed-esofago