Tarlatamab Medicine 03 December 2024 Extended indication Adult patients with SCLC with disease progression on or after platinum-based first line chemotherapy eligible for systemic chemotherapy Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Tarlatamab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Adult patients with SCLC with disease progression on or after platinum-based first line chemotherapy eligible for systemic chemotherapy Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Amgen Portfolio holder Amgen Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks werkingsmechanisme: DLL3 X CD3 HLE (BiTE) Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2025 Expected Registration October 2025 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Topotecan Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De resultaten uit de fase 2 studie zijn positief. De resultaten met betrekking tot mediane overleving worden nog afgewacht. Deze fase 3 studie vergelijkt monotherapie Tarlatamab met SOC (Topotecan, Lurbinectedine of Amrubicin (Japan)) als tweedelijnsbehandeling. Topotecan is een geneesmiddel met veel bijwerkingen. Indien tarlatamab effectief blijkt zal dit dus mogelijk voordelen opleveren voor de patiënt. Duration of treatment Frequency of administration 1 times every 2 weeks Dosage per administration 10 mg References * https://clinicaltrials.gov/study/NCT05740566?cond=SCLC,%20Recurrent&intr=Tarlatamab&rank=1; * Cramer-van der Welle CM, et al. Eur J Cancer Care. 2020;29:e13250. Additional remarks start-up dosis van 1mg op dag 1 in cycle 1, daarna 10mg Q2W Expected patient volume per year Patient volume < 160 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: www.IKNL.nl (https://iknl.nl/kankersoorten/longkanker); :Cramer-van der Welle CM, et al. Eur J Cancer Care. 2020;29:e13250. Additional remarks In 2021 waren er 1.637 SCLC diagnoses (1). Waarvan 70% stadium IV (1.146 patiënten). 70% wordt behandeld in de eerste lijn (802 patiënten). 40% van de in eerstelijns behandelde patiënten wordt behandeld in de tweedelijn (320 patiënten). Waarvan 50% een rechallenge CHT in de tweedelijn krijgt (160 patiënten) (2). Expected cost per patient per year Cost References Additional remarks prijs onbekend Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Eerste lijn behandeling in combinatie met platinum bevattende chemo References https://clinicaltrials.gov/study/NCT05361395?cond=SCLC,Extensive%20Stage&intr=Tarlatamab&rank=1 Additional remarks Other information Additional remarks