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Pirtobrutinib

Extended indication Mantle Cell Lymphoma (MCL)
Therapeutic value No estimate possible yet
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)
Manufacturer Eli Lilly
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
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
ATMP No
Submission date June 2022
Expected Registration July 2023
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options R-CHOP/ R-DHAP, lenalidomide, ibrutinib, bortezomib of stamceltransplantatie.
Therapeutic value No estimate possible yet
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.
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

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Chronic lymphocytic leukaemia (CLL) and small lymphocytic leukaemia (SLL) - second-line or greater
References SPS UK

Other information

There is currently no futher information available.