Retifanlimab Medicine 08 June 2021 Extended indication Patiënten met inoperabele, lokaal gevorderd of gemetastaseerd plaveiselcarcinoom van het anale kanaal. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Retifanlimab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Patiënten met inoperabele, lokaal gevorderd of gemetastaseerd plaveiselcarcinoom van het anale kanaal. Current proprietary name Already available biosimilars / generics Proprietary name Zynyz Manufacturer Incyte Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise NKI-AVL official expert center. Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date December 2024 Expected Registration November 2025 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Registration will be based on results of the POD1UM-303 phase 3, randomized, double blind, placebo controlled, no prior systemic therapy (only adjuvant CT allowed), stratified by PD-L1 expr.(<%, >=1%). Arms: reti + Pt-CT versus Pt-CT. Primary endpoint: PFS Secondary: OS, ORR, DOR, safety No results yet Therapeutic value Current treatment options Current palliative care: mostly chemo-radiation. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen gegevens bekend. Indien de therapeutische waarde gelijk blijkt aan 5FU/capecitabine zal het ingezet worden op het moment dat dit niet veilig is om toe te dienen. In het geval van bijvoorbeeld symptomen van hartfalen of cardiovasculaire bijwerkingen. Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 500 mg References NCT03597295, NCT04472429 Additional remarks Expected patient volume per year Patient volume 20 - 30 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Oncoline Additional remarks Approx. 300 new patients/year of which 10-15% locally advanced/metast. (30-45 patients) onset of disease: approx. 55-60 year, so older population Expected cost per patient per year Cost References Additional remarks Mogelijk vergelijkbare kosten met andere PD-1 remmers. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks