Entolimod Medicine 13 December 2018 Extended indication Acute radiation syndrome Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Entolimod Domain Oncology and Hematology Reason of inclusion Main indication Oncology other Extended indication Acute radiation syndrome Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Cleveland Biolabs Portfolio holder Mechanism of action Unknown Route of administration Intramuscular Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Recombinant protein that acts as an agonist of toll-like receptor 5 (TLR5). Entolimod activation of TLR5 triggers NF-kB signaling, mobilizing an innate immune response. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New medicine ATMP Unknown Submission date November 2017 Expected Registration December 2018 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Geen Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 0,4-0,6 μg/kg References Krivokrysenko et al. Predicting a human efficacious dose range for entolimod (CBLB502) based on biomarkers of its anti-radiation efficacy. Chemical and Biological Defense Science and Technology Conference, 2015. Additional remarks Eenmalige injectie Expected patient volume per year Patient volume < 17 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References EMA Additional remarks EMA orphan designation: "less than 0.01 in 10,000 people in the European Union (EU)." Voor Nederland zou dit uitkomen op 17 patienten per 17M inwoners. 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Solide tumoren, vaccin adjuvant. References Additional remarks Een mogelijk probleem bij de indicatie-uitbreiding voor solide tumoren is dat de stralenbescherming die als het werkt, ook op de tumor werkt. Op dit aspect zijn de trials niet gericht. De werkgroep verwacht dat het gebruik van entolimod voor deze indicatie dan ook laag zal zijn. Other information Additional remarks