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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.