Trilaciclib Medicine 08 December 2020 Extended indication Protects patients with small cell lung cancer against multi-lineage chemotherapy-induced myelosuppression. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Trilaciclib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Protects patients with small cell lung cancer against multi-lineage chemotherapy-induced myelosuppression. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer G1 therapeutics Portfolio holder Mechanism of action CDK4 / 6 tyrosine kinase inhibitor Route of administration Intravenous Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Actual primary completion date in juli 2018. FDA breakthrough therapy. Therapeutic value Current treatment options In de toekomst ook ALRN6924 als myelosuppressie agent. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 240 mg/m2 References NCT03041311; NCT02514447 Additional remarks Patients will receive trilaciclib 240mg/m2 administered Intraveneus once daily on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Expected patient volume per year Patient volume < 427 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Chan, B. A. (2013). Chemotherapy advances in small-cell lung cancer. Journal of thoracic disease, 5 Suppl 5(Suppl 5). Additional remarks In Nederland is er in 2017 bij 1.709 personen klein cellige longkanker geconstateerd. Bij het merendeel van de patiënten met klein cellige longkanker is op het moment van de diagnose de ziekte al uitgezaaid. Als er sprake is van uitgebreide ziekte volgt er chemotherapie. In dit geval ontwikkelt ongeveer 25% van de patiënten myelosuppressie. Dit zou betekenen dat 427 patiënten in aanmerking zouden kunnen komen. Het is op dit moment nog niet duidelijk of trilaciclib ook daadwerkelijk in de praktijk ingezet zal worden. Expected cost per patient per year Cost References Drugs.com Additional remarks De kosten voor trilaciclib intraveneus poeder voor injectie (300 mg) is $1.525 (€1.429,89) voor een levering van 1 poeder voor injectie in de Verenigde Staten. De Nederlandse prijs is nog niet bekend. 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 Breast cancer. References Adisinsight. Additional remarks Fase 2 studie. Other information Additional remarks