Nibrozeton Medicine 03 June 2025 Extended indication Nibrozetone in combination with platinum chemotherapy for third line or later treatment of small cell lung cancer in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Nibrozeton Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Nibrozetone in combination with platinum chemotherapy for third line or later treatment of small cell lung cancer in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Epicentrx Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Nibrozetone (RRx-001) is een NLRP3/KEAP1-remmer. Het bindt aan het NLRP3 inflammasoom en remt dit af, evenals Kelch-like ECH-associated protein 1 (KEAP1). Het NLRP3 inflammasoom start en bestendigt chronische ontsteking, een kenmerk van de meeste ernstige ziekten, waaronder kanker, door de productie van de ontstekingsbevorderende cytokinen IL-1β en IL-18. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date September 2026 Expected Registration October 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Maximal 3 week / weeks Frequency of administration 1 times a week Dosage per administration 4mg References NCT05566041 (REPLATINUM) Additional remarks Expected patient volume per year Patient volume < 62 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1) ; expertopinie (2) Additional remarks In 2022 zijn er 1.566 diagnoses kleincellig longcarcinoom (SCLC). 70% van de patiënten heeft stadium 4 (1.096 patiënten). Van deze patiënten krijgt 70% de eerste lijnsbehandeling (767 patiënten). Van deze patiënten krijgt 40% een tweede lijnsbehandeling (307 patiënten). 20% hiervan komt in aanmerking voor de derde lijnsbehandeling (62 patiënten). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks