Extended indication

Mantle Cell Lymphoma (MCL)

Therapeutic value

No estimate possible yet

Registration phase

Clinical trials

Product

Active substance

Pirtobrutinib

Domain

Oncology and 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 comments
Pirtobrutinib (LOXO-305) is een zeer selectieve, niet-covalente BTK-remmer van de volgende generatie (ncBTKi).

Registration

Registration route

Centralised (EMA)

ATMP

No

Submission date

2022

Expected Registration

2023

Orphan drug

No

Registration phase

Clinical trials

Therapeutic value

Current treatment options

Stamceltransplantatie, R-CHOP/ R-DHAP, lenalidomide, ibrutinib of bortezomib.

Therapeutic value

No estimate possible yet

Duration of treatment

Median month / months

Frequency of administration

1 times a day

Dosage per administration

200mg

References
Mato RA et al.Lancet 2021; 397: 892–901.
Additional comments
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 = 52%.
De fabrikant geeft aan dat de mediane behandelduur 6 maanden betreft.

Expected patient volume per year

Patient volume

57

Market share is generally not included unless otherwise stated.

References
IKNL
Additional comments
Incidentie betreft in totaal 219 patiënten in 2018 voor MCL. 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.