Pirtobrutinib Medicine 07 December 2021 Extended indication Mantle Cell Lymphoma (MCL) Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Pirtobrutinib Domain Hematology Reason of inclusion New medicine (specialité) Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Mantle Cell Lymphoma (MCL) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Eli Lilly Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Pirtobrutinib (LOXO-305) is een zeer selectieve, niet-covalente BTK-remmer van de volgende generatie (ncBTKi). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date June 2022 Expected Registration July 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options R-CHOP/ R-DHAP, lenalidomide, ibrutinib, bortezomib of stamceltransplantatie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het is een BTK-remmer met een ander aangrijpingspunt dan ibrutinib en acalabrutinib. Dit kan mogelijk een voordeel zijn. De fase 3 studie loopt nog. Duration of treatment Median 5 month / months Frequency of administration 1 times a day Dosage per administration 200mg References Mato RA et al.Lancet 2021; 397: 892–901. Key Data Presented at ASH (American Society of Hematology) 2021 Annual Meeting (Michael L. Wang) https://investor.lilly.com/news-releases/news-release-details/loxo-oncology-lilly-announces-updated-data-phase-12-bruin-1 Additional remarks Van de 61 patiënten met MCL, was het mediane aantal eerdere behandelingen dat men kreeg 3 (IQR 2–4). 57 patiënten (93%) kregen eerder een BTK inhibitor. ORR = 51%. De fabrikant geeft aan dat de mediane behandelduur 5 maanden betreft. Expected patient volume per year Patient volume 57 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL Additional remarks Incidentie betreft in totaal 219 patiënten in 2018 voor Mantle Cell Lymphoma (MC)L. De verwachting is dat er voor BTK-remmers in de 2e en 3e lijn 57 patiënten in aanmerking zullen komen. 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 Chronic lymphocytic leukaemia (CLL) and small lymphocytic leukaemia (SLL) - second-line or greater References SPS UK Additional remarks Other information Additional remarks